CDER Small Business and Industry Assistance (SBIA) Learn
Online Training Repository
The table below lists SBIA multimedia training resources, including conference/webinar presentations and recordings, online courses, newsletters and podcasts. Explore the SBIA On-Demand Learning Library to browse by most popular videos and see upcoming events for a list of future live events.
You can now find Spanish captions for selected training modules as the FDA expands language accessibility to audiences in the Latin America Region and the U.S. Click “Subtítulos en Español” to the right of the list below to use this feature. You can also find this training on our SBIA Spanish Captions YouTube playlist.
Ahora se tienen subtítulos en español para módulos de capacitación seleccionados ya que la FDA está ampliando la accesibilidad en cuanto al idioma para audiencias en la región de América Latina y los Estados Unidos. Haga clic en “Subtítulos en Español” a la derecha de la siguiente lista para utilizar esta modalidad. También puede encontrar esta capacitación en nuestra lista de reproducción en español en YouTube.
Use filters and search box to find resources
Advanced search (combine topic and search terms)
| Summary | Type | Issued/Updated | Topic | Subtítulos en Español |
|---|---|---|---|---|
| FDA's Participation in USP-NF Revision Process – Challenges and Solutions | On Demand | 12/11/2025 | Drug Development; Drug Quality; Manufacturing, USP Standards | No |
| Strengthening Your Compendial Strategy | On Demand | 12/11/2025 | Drug Development; Drug Quality; Manufacturing, USP Standards | No |
| Industry’s Engagement in USP’s Standards-Setting Process | On Demand | 12/11/2025 | Drug Development; Drug Quality; Manufacturing, USP Standards | No |
| Quality and Regulatory Predictability: Shaping USP Standards – Q&A Discussion Panel | On Demand | 12/11/2025 | Drug Development; Drug Quality; Manufacturing, USP Standards | No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration | On Demand | 5/20/2025 | User Fees; OTC Drug Registration; Registration and Listing | No |
| Certificates of Confidentiality Part 1: General Overview | On Demand | 5/7/2025 | BLA; Clinical Trials and Research; Devices; Drug Development; NDA; New Drug Development | No |
| Certificates of Confidentiality Part 2: FDA/CDER Issuance of Discretionary Certificates of Confidentiality | On Demand | 5/7/2025 | BLA; Clinical Trials and Research; Devices; Drug Development; NDA; New Drug Development | No |
| CDER Bioresearch Monitoring (BIMO): Electronic Submission Requirements for New Drug and Biologic Licensing Applications | On Demand | 5/6/2025 | BIMO; BLA; Electronic Submissions; New Drug Development; Inspections | No |
| Generic Drugs Forum (GDF) 2025: Office of Generic Drugs (OGD) Keynote | On Demand | 4/9/2025 | ANDA; Bioequivalence; Generic Drug Development | No |
| Generic Drugs Forum (GDF) 2025: Office of Pharmaceutical Quality (OPQ) Keynote | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality | No |
| ANDA Missed Goal Dates: An Update on Metrics and Internal Communications | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Meetings; FDA Meetings/Communications | No |
| Request for Reconsideration_Process Overview and Best Practices for FDA Evaluation | On Demand | 4/9/2025 | ANDA; Generic Drug Development | No |
| Request for Reconsideration Under GDUFA III – Overview and Experience from BE Perspectives | On Demand | 4/9/2025 | ANDA; Bioequivalence; Generic Drug Development | No |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 1 Session 1 | On Demand | 4/9/2025 | ANDA; Bioequivalence; Generic Drug Development; Meetings; FDA Meetings/Communications; Pharmaceutical Quality | No |
| Best Practices for Generic Drug Labeling | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Labeling | No |
| Project Managing Drug Assessors Under GDUFA III Regulations | On Demand | 4/9/2025 | ANDA; Generic Drug Development | No |
| Minor Regulatory Errors with Major Consequences | On Demand | 4/9/2025 | ANDA; Generic Drug Development | No |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 1 Session 2 | On Demand | 4/9/2025 | ANDA; Bioequivalence; Generic Drug Development; Meetings; FDA Meetings/Communications; Pharmaceutical Quality | No |
| Considerations when Submitting Proposed Excipient Levels in Inactive Ingredient Controlled Correspondences | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality | No |
| Building a Global Framework for Assessing Inactive Ingredients in Generic Drug Applications | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality | No |
| How to Leverage the Inactive Ingredient Database and Justify Excipient Safety in ANDAs | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality | No |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 1 Session 3 | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality | No |
| Product Specific Guidance (PSG) Program Overview | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence | No |
| Pre-Abbreviated New Drug Application (ANDA) Meetings: Process and Best Practices | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Meetings; FDA Meetings/Communications | No |
| Experiences from Post-Complete Response Letter Scientific Meetings in GDUFA III | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Meetings; FDA Meetings/Communications | No |
| Common Discrepancies Observed on the Form 356h with the ANDA Submission | On Demand | 4/9/2025 | ANDA; Generic Drug Development | No |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 1 Session 4 / Day 1 Closing | On Demand | 4/9/2025 | ANDA; Bioequivalence; Generic Drug Development; Meetings; FDA Meetings/Communications | No |
| General Quality Considerations of Drug Products Labeled for Alternate Dosing Administration | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality | No |
| Nitrosamine Related Guidance | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality | No |
| Bioequivalence Approaches for Nitrosamine Impacted ANDA Applications: Case Studies | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality; Bioequivalence | No |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Session Day 2 Session 1 | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality; Bioequivalence | No |
| Impact of ICH M13A Implementation on Bioequivalence Assessment: Removal of Data Due to Low Exposure | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality; Bioequivalence | No |
| Analysis of Common ANDA Major Deficiencies | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence | No |
| CommonBioequivalence Deficiencies in Abbreviated New Drug Applications for Extended-Release Drug Products | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence | No |
| Common Clinical Deficiencies in Abbreviated New Drug Applications (ANDAs) Containing Comparative Clinical Endpoint Studies | On Demand | 4/9/2025 | ANDA; Generic Drug Development | No |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 2 Session 2 | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality; Bioequivalence | No |
| GDUFA III Impact on Drug Master File (DMF) Assessment | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Drug Master Files | No |
| Common Deficiencies in Drug Master Files (DMFs) | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Drug Master Files | No |
| Common (OPQ) Deficiencies in Abbreviated New Drug Applications (ANDAs) | On Demand | 4/9/2025 | ANDA; Generic Drug Development | No |
| Navigating Challenges in Drug Manufacturing: Common Process Deficiencies and Pre-Approval Inspection Observations | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Manufacturing; Pharmaceutical Quality | No |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 2 Session 3 | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Drug Master Files; Manufacturing; Pharmaceutical Quality | No |
| Orange Book Drug Marketing Status | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence | No |
| Case Studies of Using Alternate Reference Products or Alternative Bioequivalence (BE) Approaches in Abbreviated New Drug Application (ANDA) Submissions | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence | No |
| Common Bioequivalence (BE) Information Requests (IRs): Tips for Facilitating the Review Process | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence | No |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 2 Session 4 | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence | No |
| Generic Drugs Forum (GDF) 2025: Closing Remarks | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality; Bioequivalence | No |
| Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions | On Demand | 3/13/2025 | Model Master Files | No |
| Navigating Controlled Correspondences to Support Generic Drug Development | On Demand | 2/27/2025 | ANDA; Controlled Correspondence; Generic Drug Development; Regulatory Submissions | No |
| BsUFA III Regulatory Science Pilot Program: Progress Update | On Demand | 1/22/2025 | BLA; Biologics; Biosimilars; International; Regulatory Science | No |
| FDA Clinical Investigator Training Course (CITC) 2024: Welcome and Opening Remarks | On Demand | 12/10/2024 | Chemistry Manufacturing and Controls (CMC); Clinical Trials and Research; Digital Health Technologies; Drug Safety; Good Clinical Practice; IND; Inspections; International; New Drug Development; Real World Evidence | No |
| FDA Structure and Mandate | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development | No |
| Basics of Clinical Trial Design | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development | No |
| Statistical Principles for Clinical Development | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Statistical Analysis | No |
| FDA Clinical Investigator Training Course (CITC) 2024: Q&A Discussion, Day 1 Session 1 | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Statistical Analysis | No |
| Safety Considerations in Clinical Drug Development | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Safety | No |
| Specific Populations in Clinical Trials | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development | No |
| FDA Clinical Investigator Training Course (CITC) 2024: Q&A Discussion, Day 1 Session 2 | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Safety | No |
| Chemistry, Manufacturing and Controls: Regulatory Considerations and Resources | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development ; Chemistry Manufacturing and Controls (CMC); IND | No |
| Pharmacology & Toxicology in the Investigator’s Brochure | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Safety; IND | No |
| Clinical Pharmacology: Early Drug Development | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Safety; IND | No |
| FDA Clinical Investigator Training Course (CITC) 2024: Q&A Discussion, Day 2 Session 1 | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development ; Chemistry Manufacturing and Controls (CMC); Safety | No |
| Innovative Approaches to Clinical Trials | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Real World Evidence; Digital Health Technologies | No |
| Informed Consent: More than just a document | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Good Clinical Practice | No |
| FDA Clinical Investigator Training Course (CITC) 2024: Q&A Discussion, Day 2 Session 2, Panel 1 | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Real World Evidence; Digital Health Technologies; Good Clinical Practice | No |
| mRNA Vaccines | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Vaccines; Biologics | No |
| Innovative Therapeutics: Gene Therapy | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Biologics | No |
| FDA Clinical Investigator Training Course (CITC) 2024: Q&A Discussion, Day 2 Session 2, Panel 2 | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Vaccines; Biologics | No |
| Achieving Fit-for-Purpose Clinical Trial Quality | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Real World Evidence; Digital Health Technologies; Good Clinical Practice | No |
| Investigator Responsibilities: Regulations and FDA Expectations for the Conduct of Clinical Trials | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Good Clinical Practice | No |
| International Clinical Trials | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; International | No |
| FDA Clinical Investigator Training Course (CITC) 2024: Q&A Discussion, Day 3 Session 1 | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Real World Evidence; Digital Health Technologies; Good Clinical Practice | No |
| FDA’s Good Clinical Practice Compliance Review for NDAs and BLAs | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; ; NDA; BLA; Good Clinical Practice | No |
| Clinical Investigator Inspection Readiness | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Inspections | No |
| FDA’s Use of Alternative Approaches to Evaluate GCP Compliance | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Good Clinical Practice | No |
| FDA Clinical Investigator Training Course (CITC) 2024: Q&A Discussion and Closing Remarks, Day 3 Session 2 | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; ; NDA; BLA; Good Clinical Practice; Inspections | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Keynote Address | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Bioequivalence | No |
| IVRT Methods for In Situ Depot-Forming Long-Acting Injectable Products | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Nano-Size Complex Products In Vitro Release Testing (IVRT) | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Nanotechnology | No |
| Application of Adaptive Perfusion as In Vitro Release Testing Method to Improve Understanding and Assessment of Complex Drug Products | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Q&A Discussion Day 1 Session 1 | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Current Trends in Product-Specific Guidance (PSG) Development & Revisions for Topical Products | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Bioequivalence | No |
| Enhanced Understanding of Structure Performance Relationship Using Modeling and Simulation- A Case Study with Dapsone Topical Gel | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Approaches for Evaluation of Formulation Differences on Performance of Topical Products | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Q&A Discussion Day 1 Session 2 | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Orally Inhaled Drug Product PSGs: General Considerations Using the Alternative Bioequivalence Approach In Lieu of Comparative Clinical Endpoint (CCEP) BE Study for Suspension-Based Metered Dose Inhalers | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Bioequivalence | No |
| Orally Inhaled Drug Product PSGs: Considerations for Using Modeling and Simulation with Alternative BE Approaches | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Bioequivalence | No |
| OPQR Testing & Research to Support Guidance Development of Inhalation Products | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Bioequivalence | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Q&A Discussion Day 1 Session 3 | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Drug-Device Combination Products – A New Methodology for Evaluation | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Approaches to Analyzing Comparative Use Human Factors Studies | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Combination Products | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Q&A Discussion Day 1 Session 4 | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 1 Closing Remarks | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Teriparatide Injection First Generic Approval: Quality-Related Review Considerations | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Quality Considerations for First Generic Oral Liquids | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Quality Considerations for First Generic Tiotropium Bromide Capsule-Based Dry Powder Inhalers (DPIs) | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Q&A Discussion Day 2 Session 5A | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Totality of Evidence Including Physiologically Based Pharmacokinetic (PBPK) Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets (Part I) | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Totality of Evidence Including Physiologically Based Pharmacokinetic (PBPK) Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets (Part II) | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Emerging Generic Oligonucleotides -Challenges and Progress | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| The Journey of First Approvals of Complex Generic Long-acting Injectable Products | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Q&A Discussion Day 2 Session 5B | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Guidance for Industry: Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Analysis of First-Cycle BE Adequacy and Major BE Deficiencies Encountered | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| Analysis of ANDA Approval and Major DeficienciesA Case Study with Topical Products | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment | No |
| ICH M13A: First ICH Guideline for Bioequivalence | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Bioequivalence | No |
| Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs: First-Year Review | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Bioequivalence; FDA Meetings/Communications; Meetings | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Q&A Discussion Day 2 Session 6 | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment; Bioequivalence; FDA Meetings/Communications; Meetings | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Closing Remarks | On Demand | 9/24/2024 | Registration and Listing | No |
| Public Health Impact of Registration and Listing Data | On Demand | 9/12/2024 | Registration and Listing | No |
| CDER Direct Establishment Registration Demo | On Demand | 9/12/2024 | Registration and Listing | No |
| Establishment Registration Highlights | On Demand | 9/12/2024 | Registration and Listing | No |
| Complying with Establishment Registration Requirements | On Demand | 9/12/2024 | Registration and Listing | No |
| CDER Direct Labeler Code Request Demo | On Demand | 9/12/2024 | Registration and Listing | No |
| Labeler Code Request Highlights | On Demand | 9/12/2024 | Registration and Listing | No |
| Complying with Labeler Code Request Requirements | On Demand | 9/12/2024 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 - Q&A Discussion Panel 1 | On Demand | 9/12/2024 | Registration and Listing | No |
| CDER Direct Drug Listing | On Demand | 9/12/2024 | Registration and Listing | No |
| Listing Updates and Blanket “No Changes” Certification Demo | On Demand | 9/12/2024 | Registration and Listing | No |
| Drug Listing Highlights | On Demand | 9/12/2024 | Registration and Listing | No |
| Complying with Drug Listing Requirements | On Demand | 9/12/2024 | Registration and Listing | No |
| NDC Reservation | On Demand | 9/12/2024 | Registration and Listing | No |
| Future Format of the National Drug Code | On Demand | 9/12/2024 | Registration and Listing | No |
| NDC Assignment to Drugs | On Demand | 9/12/2024 | Registration and Listing | No |
| OTC Drug Listing Updates and Validation | On Demand | 9/12/2024 | Registration and Listing | No |
| Drug Amount Reporting for Listed Drugs | On Demand | 9/12/2024 | Registration and Listing | No |
| Who Should Not Register or List | On Demand | 9/12/2024 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 - Case Studies | On Demand | 9/12/2024 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 - Q&A Discussion Panel 2 | On Demand | 9/12/2024 | Registration and Listing | No |
| National Cancer Institute SBIR Development Center: Funding & Resources for Small Businesses | On Demand | 9/4/2024 | New Drug Development; FDA Meetings/Communications Clinical Trials; Drug Development | No |
| Overview of CDER’s Small Business & Industry Assistance (SBIA) | On Demand | 9/4/2024 | New Drug Development; FDA Meetings/Communications; Drug Development | No |
| FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA - A Reflection on Today’s Seminar’s Title | On Demand | 9/4/2024 | Biologics; Chemistry, Manufacturing, and Controls (CMC); Clinical Trials and Research; Devices; Digital Health Technologies; Drug Development; Clinical Trials | No |
| Overview of CDER Regulatory Resources CMC for pre-IND/IND Submissions - Chemistry, Manufacturing and Controls: Regulatory Considerations and Resources | On Demand | 9/4/2024 | Chemistry, Manufacturing, and Controls (CMC); Clinical Trials and Research; Devices; Digital Health Technologies; Drug Development | No |
| Overview of CDER Nonclinical Resources and Guidance for Approaching First-in-Human (FIH) Studies in Oncology | On Demand | 9/4/2024 | Chemistry, Manufacturing, and Controls (CMC); Clinical Trials and Research; Drug Development; Clinical Trials | No |
| CDER’s Clinical Consideration for First-in-Human Trials | On Demand | 9/4/2024 | Chemistry, Manufacturing, and Controls (CMC); Clinical Trials and Research; Drug Development; Clinical Trials | No |
| FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA - Q&A Discussion Panel 1 | On Demand | 9/4/2024 | Chemistry, Manufacturing, and Controls (CMC); Clinical Trials and Research; Devices; Digital Health Technologies; Drug Development; Clinical Trials | No |
| CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) - Who We Are and What We Do | On Demand | 9/4/2024 | Biologics; Clinical Trials and Research; Drug Development; Clinical Trials | No |
| Regulatory Resources and Avenues for Obtaining Early Guidance from CBER/OTP | On Demand | 9/4/2024 | Biologics; Clinical Trials and Research; Drug Development; Clinical Trials; FDA Meetings and Communications; Meetings | No |
| CBER’s CMC Considerations for Early Phase Studies of Cell and Gene Therapy Products | On Demand | 9/4/2024 | Biologics; Clinical Trials and Research; Drug Development; Clinical Trials; Chemistry Manufacturing and Controls (CMC) | No |
| Nonclinical Assessment of Cell and Gene Therapy (CGT) Products to Support an IND | On Demand | 9/4/2024 | Biologics; Clinical Trials and Research; Drug Development; Clinical Trials; Chemistry Manufacturing and Controls (CMC) | No |
| Early Development of Cellular and Gene Therapy in Oncology -Clinical Consideration | On Demand | 9/4/2024 | Biologics; Clinical Trials and Research; Drug Development; Clinical Trials; Chemistry Manufacturing and Controls (CMC) | No |
| FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA – Q&A Discussion Panel 2 | On Demand | 9/4/2024 | Biologics; Clinical Trials and Research; Drug Development; Clinical Trials; Chemistry Manufacturing and Controls (CMC) | No |
| How Can DICE Help You? | On Demand | 9/4/2024 | Chemistry, Manufacturing, and Controls (CMC); Clinical Trials and Research; Devices; Digital Health Technologies; Drug Development; Clinical Trials | No |
| CDRH Medical Device Development Tools (MDDT) Program | On Demand | 9/4/2024 | Chemistry, Manufacturing, and Controls (CMC); Clinical Trials and Research; Devices; Digital Health Technologies; Drug Development; Clinical Trials | No |
| Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force | On Demand | 9/4/2024 | Chemistry, Manufacturing, and Controls (CMC); Clinical Trials and Research; Devices; Digital Health Technologies; Drug Development; Clinical Trials | No |
| FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA – Q&A Discussion Panel 3 | On Demand | 9/4/2024 | Chemistry, Manufacturing, and Controls (CMC); Clinical Trials and Research; Devices; Digital Health Technologies; Drug Development; Clinical Trials | No |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development – Keynote Address | On Demand | 5/29/2024 | Advanced Manufacturing; Artificial Intelligence; Biologics; Clinical Trials and Research; Combination Products; Devices; Drug Safety; Drug Supply Chain; Electronic Submissions; New Drug Development | No |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development – Plenary Session | On Demand | 5/29/2024 | Advanced Manufacturing; Artificial Intelligence; Biologics; Clinical Trials and Research; Combination Products; Devices; Drug Safety; Drug Supply Chain; Electronic Submissions; New Drug Development | No |
| Selective Safety Data Collection in Clinical Trials | On Demand | 5/29/2024 | Clinical Trials and Research; Drug Safety; New Drug Development | No |
| The CDER Center for Clinical Trial Innovation (C3TI) | On Demand | 5/29/2024 | Artificial Intelligence; Clinical Trials and Research; New Drug Development | No |
| Responsive Regulation of Artificial Intelligence in Drug Development | On Demand | 5/29/2024 | Advanced Manufacturing; Artificial Intelligence; Clinical Trials and Research; New Drug Development | No |
| ClinicalTrials.gov: Meeting Transparency and Reporting Requirements | On Demand | 5/29/2024 | Clinical Trials and Research; Electronic Submissions; New Drug Development | No |
| Diversity in Clinical Trials: Drug Trials Snapshots Perspective | On Demand | 5/29/2024 | Artificial Intelligence; Clinical Trials and Research; New Drug Development | No |
| Combination Products: Updates and Best Practices | On Demand | 5/29/2024 | Combination Products; New Drug Development | No |
| Leveraging Small Business and Industry Assistance (SBIA) Resources | On Demand | 5/29/2024 | New Drug Development; FDA Meetings/Communications | No |
| Improving Informed Consent | On Demand | 5/29/2024 | Clinical Trials and Research; Good Clinical Practice; New Drug Development | No |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development - Q&A Discussion Panel 1 | On Demand | 5/29/2024 | Clinical Trials and Research; Drug Safety; New Drug Development; Good Clinical Practice; Electronic Submissions | No |
| ECTD v4.0 Implementation Update | On Demand | 5/29/2024 | Electronic Submissions; New Drug Development | No |
| FDA CDER NextGen Portal | On Demand | 5/29/2024 | Electronic Submissions; New Drug Development | No |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development - Q&A Discussion Panel 2 | On Demand | 5/29/2024 | Electronic Submissions; New Drug Development | No |
| FDA Electronic Submission Gateway – Next Generation (NextGen) | On Demand | 5/29/2024 | Electronic Submissions; New Drug Development | No |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development - Q&A Discussion Panel 3 | On Demand | 5/29/2024 | Electronic Submissions; New Drug Development | No |
| Artificial Intelligence/Machine Learning: The New Frontier of Drug Development & Regulation | On Demand | 5/29/2024 | Advanced Manufacturing; Artificial Intelligence; Clinical Trials and Research; New Drug Development | No |
| Reimagining Clinical Research: The Transformation of Trial Design & Conduct | On Demand | 5/29/2024 | Advanced Manufacturing; Artificial Intelligence; Clinical Trials and Research; New Drug Development; Good Clinical Practice | No |
| The Advanced Manufacturing Technologies Designation Program | On Demand | 5/29/2024 | Advanced Manufacturing; Artificial Intelligence; Clinical Trials and Research; New Drug Development | No |
| Compliance Approaches to Emerging Threats | On Demand | 5/29/2024 | Clinical Trials and Research; New Drug Development | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Office of Generic Drugs Keynote: Collaboration and Tools for Success | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Controlled Correspondence; Generic Drug Development; Meetings; Product Specific Guidances; Pharmaceutical Quality | No |
| Key Components to Assure Pharmaceutical Quality | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Pharmaceutical Quality | No |
| FDA’s Role in Preventing and Mitigating Drug Shortages | On Demand | 4/10/2024 | ANDA; Drug Shortages | No |
| GDUFA III Policy Accomplishments | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Pharmaceutical Quality | No |
| GDUFA III Suitability Petitions | On Demand | 4/10/2024 | ANDA; Bioequivalence; Generic Drug Development; | No |
| Overview of the FDA Product-Specific Guidance (PSG) Program | On Demand | 4/10/2024 | ANDA; Bioequivalence; Generic Drug Development; | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Q&A Discussion Day 1 Panel 1 | On Demand | 4/10/2024 | ANDA; Bioequivalence; Generic Drug Development; Pharmaceutical Quality; Drug Shortages | No |
| Overview of ControlledCorrespondence: GDUFA III Updates and a Comprehensive Analysisof Controlled CorrespondenceReceived by the Office of Bioequivalence | On Demand | 4/10/2024 | ANDA; Controlled Correspondence; Generic Drug Development; Meetings; FDA Meetings/Communications | No |
| Overview of Quality-Related Controlled Correspondence (CC) | On Demand | 4/10/2024 | ANDA; Controlled Correspondence; Generic Drug Development; Meetings; FDA Meetings/Communications | No |
| Overview and Considerations of Pre-ANDA Scientific Meetings Under GDUFA III | On Demand | 4/10/2024 | ANDA; FDA Meetings/Communications; Generic Drug Development; Meetings | No |
| Unveiling the Data: Post-Complete Response Letter Scientific Meeting Requests under GDUFA III | On Demand | 4/10/2024 | ANDA; FDA Meetings/Communications; Generic Drug Development; Meetings | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Q&A Discussion Day 1 Panel 2 | On Demand | 4/10/2024 | ANDA; Controlled Correspondence; Generic Drug Development; Meetings; FDA Meetings/Communications | No |
| ANDA Program Statistics | On Demand | 4/10/2024 | ANDA; Generic Drug Development | No |
| ANDA Project Management Topics: PLAIR and Cover Letter Attachments | On Demand | 4/10/2024 | ANDA; Generic Drug Development; FDA Meetings/Communications; Regulatory Submissions | No |
| Best Practices from Regulatory Business Process Manager (RBPM) Perspective and Communications | On Demand | 4/10/2024 | ANDA; Generic Drug Development; FDA Meetings/Communications; Regulatory Submissions | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Q&A Discussion Day 1 Panel 3 | On Demand | 4/10/2024 | ANDA; Generic Drug Development; FDA Meetings/Communications; Regulatory Submissions | No |
| Pediatric Excipient Evaluation: BE Perspective | On Demand | 4/10/2024 | ANDA; Bioequivalence; Generic Drug Development; Pediatric | No |
| GDSA-BE: Modernizing Bioequivalence Assessment for Abbreviated New Drug... | On Demand | 4/10/2024 | ANDA; Bioequivalence; Generic Drug Development | No |
| Bio-IND Best Practices: An Analysis of Common Clinical Safety Hold and... | On Demand | 4/10/2024 | ANDA; Drug Safety; Generic Drug Development; Regulatory Submissions | No |
| Comparative Analyses Update | On Demand | 4/10/2024 | ANDA; Drug Safety; Generic Drug Development; Regulatory Submissions | No |
| Successful Practices for Pharmacology/Toxicology Justification in ANDAs | On Demand | 4/10/2024 | ANDA; Drug Safety; Generic Drug Development; Regulatory Submissions | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Q&A Discussion Day 2 Panel 1 | On Demand | 4/10/2024 | ANDA; Drug Safety; Generic Drug Development; Regulatory Submissions; Pediatric | No |
| Nitrosamine Risk Assessment in Type II DMFs Supporting GDUFA Applications | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Drug Master File; Pharmaceutical Quality | No |
| Post-approval changes in Complex Generics from Drug Product/CMC Perspectives | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Complex Generic Drug; Generic Drug Development; Meetings; Pharmaceutical Quality | No |
| Quality Considerations for Topical Ophthalmic Drug Products –Guidance for Industry | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Complex Generic Drug; Generic Drug Development; Meetings; Pharmaceutical Quality | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Q&A Discussion Day 2 Panel 2 | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Complex Generic Drug; Generic Drug Development; Meetings; Pharmaceutical Quality; Drug Master File | No |
| ANDA Submission: Risk-Based Extractable and Leachable Quality Information | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Controlled Correspondence; Generic Drug Development; Meetings; Product Specific Guidances; Pharmaceutical Quality | No |
| Facility Assessment for Pre-Marketing Applications: Inspections and Remote Regulatory Assessments | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Pharmaceutical Quality; Inspections | No |
| GDUFA-III Implementation –Facility Related Updates | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Pharmaceutical Quality; Inspections | No |
| ETP and AMTDP: Which Program is Right for Me? | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Controlled Correspondence; Generic Drug Development; Meetings; Product Specific Guidances; Pharmaceutical Quality | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Q&A Discussion Day 2 Panel 3 | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Controlled Correspondence; Generic Drug Development; Meetings; Product Specific Guidances; Pharmaceutical Quality; Inspections | No |
| Improving the Sterility Assurance Application to the FDA | On Demand | 4/10/2024 | ANDA; Chemistry Manufacturing and Controls (CMC); Generic Drug Development; Pharmaceutical Quality; Inspections; Regulatory Submissions | No |
| The Bacterial Endotoxins Specification –Points to Consider | On Demand | 4/10/2024 | ANDA; Chemistry Manufacturing and Controls (CMC); Generic Drug Development; Pharmaceutical Quality; Inspections; Regulatory Submissions | No |
| ANDAs Labeling Requirements for Rx to OTC Switched Products | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Labeling; OTC Drug Regulation; Regulatory Submissions | No |
| Regulatory Reminders to the Finish Line | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Regulatory Submissions | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Q&A Discussion Day 2 Panel 4 | On Demand | 4/10/2024 | ANDA; Chemistry Manufacturing and Controls (CMC); Generic Drug Development; Pharmaceutical Quality; OTC Drug Regulations; Labeling; Regulatory Submissions | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access - Closing Remarks | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Controlled Correspondence; Generic Drug Development; Meetings; Product Specific Guidances; Pharmaceutical Quality; Labeling; Complex Generic Drug; Regulatory Submissions; Inspections | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium – Day One Opening Remarks and Keynote Address | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; BLA; Digital Health Technologies; International; Regulatory Assessment; Inspections | No |
| Updates: ICH E6(R3) Good Clinical Practice (GCP) Harmonization: Updates to ICH E6(R3) | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections | No |
| Technology in Clinical Trials- Digital Health Technology (DHT) | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Digital Health Technologies | No |
| Clinical Trials with Decentralized Elements and GCP Inspections | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Digital Health Technologies; Regulatory Assessment | No |
| Good Data Governance Practice Updates | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Regulatory Assessment | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium – Day 1 Q&A Panel Sessions 1-4 | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Digital Health Technologies; International; Regulatory Assessment; Inspections | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium – Day 1 Wrap Up & Closing Remarks | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Digital Health Technologies; International; Regulatory Assessment; Inspections | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - Day 2 Opening Remarks | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; BLA; Digital Health Technologies; International; Regulatory Assessment; Inspections | No |
| Sponsor Oversight in Clinical Trials | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Regulatory Assessment | No |
| Clinical Trials Post-Pandemic - Positive Disruption to Establish Ways of Working? | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment | No |
| The Future of GCP Inspections | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Good Clinical Practice; Regulatory Assessment; Inspections | No |
| Agency Updates: Policies, Guidances, and Initiatives | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Good Clinical Practice; Regulatory Assessment; Inspections | No |
| Collaboration Between Agencies and Future Expectations | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; BLA; Digital Health Technologies; International; Regulatory Assessment; Inspections | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - Day 2 Panel Discussions 1-5 | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Good Clinical Practice; Regulatory Assessment; Inspections | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - Day 2 Wrap-Up and Closing Remarks | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Good Clinical Practice; Regulatory Assessment; Inspections | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - Day 3 Opening Remarks | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; BLA; Digital Health Technologies; International; Regulatory Assessment; Inspections | No |
| Bioequivalence: Remote Evaluations | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; International; Regulatory Assessment; Inspections | No |
| Bioequivalence: Bioanalytical Issues | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; International; Regulatory Assessment; Inspections | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - Bioequivalence: Day 3 Q&A Discussion Panel 1 | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; International; Regulatory Assessment; Inspections | No |
| Bioequivalence: Clinical Study Conduct | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Good Clinical Practice; International; Regulatory Assessment; Inspections | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - Bioequivalence: Day 3 Q&A Discussion Panel 2 | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; International; Regulatory Assessment; Inspections; Good Clinical Practice | No |
| Pharmacovigilance Compliance | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections; Safety | No |
| Pharmacovilgilance: International Collaboration | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections; Safety | No |
| Pharmacovilgilance: Future of Inspections | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections; Safety | No |
| Pharmacovilgilance: Regulatory Updates | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections; Safety | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - Pharmacovilgilance: Day 3 Q&A Discussion Sessions 4-6 | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections; Safety | No |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium - Symposium Wrap-up and Closing | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; BLA; Digital Health Technologies; International; Regulatory Assessment; Inspections; Good Clinical Practice | No |
| Joint US FDA – Health Canada ICH Public Meeting - Opening Remarks | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management; Good Clinical Practice | No |
| ICH Overview | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management | No |
| Updates on ICH Efficacy Related Guidelines: M12, Drug Interaction Studies | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management | No |
| Update on E2D(R1) | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management | No |
| Good Clinical Practice: ICH E6(R3) | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management; Good Clinical Practice | No |
| M14, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management | No |
| Q2(R2)/Q14 Revision of Q2(R1) Analytical Validation and Analytical Procedure Development | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management | No |
| Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management | No |
| Q9(R1) Quality Risk Management | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management | No |
| Cell & Gene Therapy Discussion Group (CGT DG) | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management | No |
| Joint US FDA – Health Canada ICH Public Meeting: Q&A Discussion Panel & Closing Remarks | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management; Good Clinical Practice | No |
| Generic Drugs Forum (GDF) 2026 | Conference | 4/22/2026 | ANDA, Bioequivalence, Controlled Correspondence, Generic Drug Development, Manufacturing, Pharmaceutical Quality, Product Specific Guidances | No |
| Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers | Webinar | 4/15/2026 | Expanded Access, IND, Regulatory Submissions | No |
| Quality and Regulatory Predictability: Shaping USP Standards | Webinar | 12/11/2025 | Drug Development, Drug Quality, Manufacturing, USP Standards, | No |
| FDA Electronic Drug Registration and Listing (eDRLS) using CDER Direct Training Modules | On Demand | 7/24/2025 | Import/Export, International, Registration and Listing | No |
| FDA Pharmaceutical Quality Training Modules | On Demand | 7/24/2025 | Drug Quality, Quality Assessments, Supply Chain, Manufacturing, Emerging Technology, Generic Drug Development | No |
| FDA Clinical Trials Training Modules | On Demand | 7/24/2025 | Chemistry Manufacturing and Controls (CMC), Clinical Trials and Research, Digital Health Technologies, Drug Safety, Good Clinical Practice, IND, Inspections, International, New Drug Development, Real World Evidence | No |
| FDA Advancing Generic Drug Development Training Modules | On Demand | 7/24/2025 | ANDA, Complex Generic Drug, Product Specific Guidances, Generic Drug Development, Regulatory Assessment, Biomarkers, Bioequivalence, Topical Products, Orally Inhaled Products, Complex Injectables | No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration | Webinar | 5/20/2025 | OTC Drug Regulation, User Fees | No |
| FDA CDER Overview: Certificates of Confidentiality | On Demand | 5/07/2025 | BLA, Clinical Trials and Research, Devices, Drug Development, NDA, New Drug Development | No |
| CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications | On Demand | 5/06/2025 | BIMO, BLA, Electronic Submissions, New Drug Development, Inspections | No |
| Navigating Controlled Correspondences to Support Generic Drug Development | Webinar | 2/27/2025 | ANDA, Controlled Correspondence, Generic Drug Development, Regulatory Submissions | No |
| Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions | Webinar | 3/13/2025 | ANDA, Drug Master Files, Generic Drug Development, Model Master Files, Regulatory Submissions | No |
| Improving Data Quality with Centralized Statistical Monitoring with Dr. Paul Schuette and Xiaofeng (Tina) Wang | SBIA Chronicles Podcast | 12/13/2024 | Statistical Analysis | No |
| Generic Drugs Forum (GDF) 2025 | Conference | 4/9/2025 | ANDA, Bioequivalence, Generic Drug Development | No |
| BsUFA III Regulatory Science Pilot Program: Progress Update | Webinar | 1/22/2025 | BLA; Biologics; Biosimilars; International; Regulatory Science | No |
| FDA Clinical Investigator Training Course (CITC) 2024 | Conference | 12/10/2024 | Chemistry Manufacturing and Controls (CMC), Clinical Trials and Research, Digital Health Technologies, Drug Safety, Good Clinical Practice, IND, Inspections, International, New Drug Development, Real World Evidence | No |
| Clinical Pharmacology Considerations for Novel Therapeutic Modalities | Webinar | 12/4/2024 | Antibody Drug Conjugates, Clinical Pharmacology, Clinical Trials and Research, Drug Safety, IND, International, New Drug Development, Oligonucleotide Therapeutics | No |
| M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance | Webinar | 11/21/2024 | ANDA, Bioequivalence, Generic Drug Development, International | No |
| The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball | SBIA Chronicles Podcast | 11/14/2024 | Artificial Intelligence | No |
| Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies | Webinar | 11/12/2024 | Clinical Pharmacology, Clinical Trials and Research, Drug Safety, IND, International, New Drug Development, Radiolabeled Mass Balance | No |
| Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation | Webinar | 11/7/2024 | ANDA, BLA, Drug Safety, New Drug Development, Risk Management, Risk Evaluation and Mitigation Strategy (REMS) | No |
| Global IDMP Implementation - Getting Closer to the Goal | Webinar | 10/16/2024 | Data Standards, Drug Shortages, Labeling, Electronic Submissions, Pharmacovigilance, Regulatory Submissions | No |
| ICH M12 Drug-Drug Interaction Studies Final Guidance | Webinar | 10/9/2024 | Drug Interaction, New Drug Development, IND | No |
| Advancing Generic Drug Development: Translating Science to Approval 2024 | Conference/Workshop | 9/24/2024 | ANDA, Complex Generic Drug, Product Specific Guidances, Generic Drug Development, Regulatory Assessment | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 | Conference/Workshop | 9/12/2024 | Import/Export, International, Registration and Listing | No |
| ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA | Webinar | 9/10/2024 | ANDA, Generic Drug Development, Regulatory Submissions | No |
| FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA | Webinar | 9/4/2024 | Biologics, Chemistry, Manufacturing, and Controls (CMC), Clinical Trials and Research, Early Product Development, Devices, Digital Health Technologies, Drug Development | No |
| Environmental Monitoring in Compounding | Webinar | 7/30/2024 | Compounding, Environmental Monitoring, Outsourcing Facilities | No |
| Dataset-JSON Pilot Report and Next Steps | Webinar | 7/25/2024 | Data Standards, International, Regulatory Science, Regulatory Submissions | No |
| Introduction to FDA’s Office of Trade and Global Partnerships | Webinar | 7/23/2024 | Combination Products, Drug Supply, International Trade | No |
| Office of Pharmaceutical Quality (OPQ) Reorganization | On Demand | 7/16/2024 | Drug Quality, Emerging Technology, International, Manufacturing, Quality Assessments, Supply Chain | No |
| Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule | Webinar | 6/26/2024 | Advertising, Marketing, Regulatory Submissions | No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration | Webinar | 6/18/2024 | OTC Regulation, User Fees | No |
| OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites | Webinar | 6/13/2024 | Animal Rule, Bioanalysis, Bioavailability, Bioequivalence, Clinical Trials and Research, Good Laboratory Practice | No |
| Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development | Conference/Workshop | 5/29/2024 | Advanced Manufacturing, Artificial Intelligence, Biologics, Clinical Trials and Research, Combination Products, Devices, Drug Safety, Drug Supply Chain, Electronic Submissions, New Drug Development | No |
| Considerations for Drug Products that Contain Nanomaterials | SBIA Chronicles Podcast | 5/17/2024 | Nanomaterials | No |
| Considerations for Drug Products that Contain Nanomaterials | SBIA Chronicles | 5/17/2024 | Nanomaterials | No |
| Statistical Considerations for Premarketing Risk Assessment | Webinar | 5/16/2024 | Clinical Trials and Research, New Drug Development, Integrated Safety Analyses | No |
| Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval | Webinar | 5/9/2024 | ANDA, Generic Drug Development, Meetings, Regulatory Assessments | No |
| Facilitating Generic Drug Product Development through Product-Specific Guidances | Webinar | 4/25/2024 | ANDA, Bioequivalence, Generic Drug Development, Product Specific Guidances | No |
| Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access | Conference/Workshop | 4/10/2024 | ANDA, Bioequivalence, Chemistry Manufacturing and Controls (CMC), Controlled Correspondence, Generic Drug Development, Meetings, Product Specific Guidances | No |
| Expanding Generic Drug Access Through International Engagements | Webinar | 2/28/2024 | ANDA, Bioequivalence, Clinical Trials and Research, Complex Generic Drug, Generic Drug Development, International | No |
| Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes | Webinar | 3/7/2024 | Clinical Trials and Research, New Drug Development, Integrated Safety Analyses | No |
| Joint US FDA – Health Canada ICH Public Meeting | Webinar | 2/22/2024 | International, New Drug Development, Generic Drug Development, Safety, Real Word Evidence, Analytical Validation, Drug Safety, Data Management | No |
| A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs | Webinar | 1/18/2024 | Generic Drug Development, Bioequivalence, ANDA, Meetings | No |
| ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues | Webinar | 4/28/2021 | ANDA; Generic Drug Development; Quality Assessments | Disponible/Available |
| A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium | Symposium | 2/13/2024 | New Drug Development, Clinical Trials and Research, ANDA, Bioequivalence, BLA, Digital Health Technologies, International, Regulatory Assessment, Inspections | No |
| Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources | Webinar | 12/12/2023 | IND, Labeling, Drug Interaction, Therapeutic Protein | No |
| FDA Clinical Investigator Training Course (CITC) 2023 | Conference/Workshop | 12/6/2023 | IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies | No |
| Toward Global IDMP Implementation: A Focus on Global Use Cases | Webinar | 11/28/2023 | Regulatory Submissions, Data Standards | No |
| Common Issues with SEND Data Submitted for Safety Pharmacology Studies | Webinar | 11/16/2023 | Regulatory Submissions, Data Standards | No |
| Implementing DSCSA: Stabilization Period and Expectations | Webinar | 11/3/2023 | DCSA, Compliance, Drug Supply Chain, Wholesaler, Distributor, Unique Serial Numbers | No |
| Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing | Symposium | 10/31/2023 | Drug Quality, Quality Assessments, Supply Chain, Manufacturing, Emerging Technology | No |
| BsUFA III Regulatory Science Pilot Program | Webinar | 10/16/2023 | Biomarkers, Regulatory Science, BLA, Biologics | No |
| 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials | Symposium | 10/11/2023 | Generic Drug Development, New Drug Development, IND, NDA, BLA, ANDA, Nanomaterials, Non-Clinical, Quality Assessment, Continuous Manufacturing, Regulatory Science, Delivery System, Lipid, Liposome | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023 | Conference/Workshop | 9/28/2023 | Registration and Listing, Import/Export | No |
| Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials | Conference/Workshop | 9/18/2023 | Clinical Trials and Research, New Drug Development, Biomarkers, Surrogate Endpoints, Noninvasive tests, Noncirrhotic NASH | No |
| Advancing Generic Drug Development: Translating Science to Approval 2023 | Conference/Workshop | 9/13/2023 | ANDA, Generic Drug Development, Complex Generic Drug, Product Specific Guidances, Regulatory Assessment | No |
| Understanding FDA Inspections and Data | Webinar | 9/6/2023 | Inspections, International, Current Good Manufacturing Practice (CGMP) | No |
| OTC Monograph Reform: OMOR Format and Content & Electronic Submissions | Webinar | 8/22/2023 | OTC Drug Regulation, Regulatory Submissions, ANDA, NDA, New Drug Development | No |
| Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products | SBIA Chronicles Podcast | 8/17/2023 | Clinical Trials and Research | No |
| Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products | SBIA Chronicles | 8/17/2023 | Clinical Trials and Research | No |
| ClinicalTrials.gov – a Three-Part Series | Webinar | 8/9/2023 | ClinicalTrials.gov, Clinical Trials and Research | No |
| Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products | SBIA Chronicles | 7/11/2023 | Generic Drug Development | No |
| Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products | SBIA Chronicles Podcast | 7/11/2023 | Generic Drug Development | No |
| Decentralized Clinical Trials (DCT) Draft Guidance | Webinar | 6/20/2023 | Clinical Trials and Research, IND, New Drug Development | No |
| Overview: Clinical Pharmacology Considerations for Food Effect Studies | Webinar | 6/15/2023 | Drug Development, Regulatory Submissions | No |
| Regulatory Education for Industry (REdI) Annual Conference 2023 | Conference/Workshop | 6/5/2023 | BLA, Chemistry Manufacturing and Controls (CMC), Digital Health Technologies, Drug Development, FDA Meetings/Communications, IND, NDA, New Drug Development, Real World Evidence, and Regulatory Submissions | No |
| An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) | Webinar | 5/24/2023 | Drug Quality, Regulatory Submissions, and Quality Assessments | No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration | Webinar | 5/16/2023 | OTC Drug Regulation, User Fees | No |
| A Deep Dive: GDUFA III Scientific Meetings | Webinar | 5/15/2023 | ANDA, Generic Drug Development, FDA Meetings/Communications | No |
| Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms” | Webinar | 5/2/2023 | Generic Drug Development, International | No |
| Electronic Systems, Electronic Records, and Electronic Signatures Webinar | Webinar | 4/25/2023 | New Drug Development, Clinical Trials and Research, IND | No |
| FDA’s Dosage and Administration Section of Labeling Draft Guidance | Webinar | 4/19/2023 | Labeling | No |
| The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development | SBIA Chronicles Podcast | 4/10/2023 | Biosimilars | No |
| The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development | SBIA Chronicles | 4/10/2023 | Biosimilars | No |
| Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF | Conference/Workshop | 4/7/2023 | Generic Drug Development | No |
| A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence | Webinar | 3/14/2023 | Bioequivalence, Generic Drug Development, Drug Development | No |
| Joint US FDA – Health Canada ICH Public Meeting | Webinar | 2/24/2023 | Clinical Trials and Research, International, New Drug Development | No |
| Overview: Clinical Pharmacology Considerations for Neonatal Studies | Webinar | 2/15/2023 | Clinical Trials and Research, IND, NDA, BLA, New Drug Development | No |
| FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds | SBIA Chronicles | 2/6/2023 | Drug Quality | No |
| FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds | SBIA Chronicles Podcast | 2/6/2023 | Drug Quality | No |
| Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use | Webinar | 2/1/2023 | OTC Drug Regulation | No |
| FDA’s Labeling Resources for Human Prescription Drugs | Webinar | 1/26/2023 | Labeling | No |
| Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards | Webinar | 1/13/2023 | Regulatory Submissions, Safety | No |
| What to Expect after an Inspection: 483s, Responses and Beyond | Webinar | 12/14/2022 | Compliance, Compounding, Inspections, FDA Form 483 | No |
| FDA Clinical Investigator Training Course (CITC) 2022 | Conference/Workshop | 12/7/2022 | IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies | No |
| Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions | Conference/Workshop | 11/30/2022 | ANDA, Drug Master Files, Generic Drug Development, Regulatory Submissions, Quality Assessments | No |
| Proposed Rule: Revising the National Drug Code Format and Drug Label Barcode Requirements | Webinar | 11/17/2022 | Registration and Listing | No |
| An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations | Webinar | 10/26/2022 | Drug Development, New Drug Development, Bioequivalence, Bioavailability, IND, NDA | No |
| FDA NanoDay Symposium 2022 | Symposium | 10/11/2022 | Generic Drug Development, New Drug Development, IND, NDA, Chemistry Manufacturing and Controls (CMC), Nanomaterials, Non-Clinical, ANDA | No |
| Study Data Standards Update for CBER: Your Guide to a Successful Submission | Webinar | 10/6/2022 | Data Standards, Regulatory Submissions | No |
| The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | SBIA Chronicles | 9/29/2022 | Compounding | No |
| The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities | SBIA Chronicles Podcast | 9/29/2022 | Compounding | No |
| Advancing Generic Drug Development: Translating Science to Approval | Conference/Workshop | 9/20/2022 | Generic Drug Development, Drug Quality, Regulatory Submissions | No |
| Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act | Webinar | 9/8/2022 | Registration and Listing | No |
| Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines | Conference/Workshop | 8/16/2022 | Drug Development, Drug Quality, Generic Drug Development, New Drug Development, IND, International, Post Approval | No |
| Best Practices for Topical Generic Product Development and ANDA Submission | Webinar | 8/11/2022 | Generic Drug Development | No |
| Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use | Webinar | 8/10/2022 | Generic Drug Development | No |
| Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites | Conference/Workshop | 7/19/2022 | Drug Development, Inspections, New Drug Development, IND | No |
| An FDA Self-Audit of Continuous Manufacturing for Drug Products | SBIA Chronicles | 6/28/2022 | Drug Quality | No |
| An FDA Self-Audit of Continuous Manufacturing for Drug Products | SBIA Chronicles Podcast | 6/28/2022 | Drug Quality | No |
| Regulatory Education for Industry (REdI) Annual Conference 2022 | Conference/Workshop | 6/6/2022 | Biosimilars, Drug Development, DSCSA, FDA Meetings/Communications, Inspections, NDA, New Drug Development, Regulatory Submissions, Resources, Safety | No |
| Quality Management Maturity Workshop | Webinar | 5/24/2022 | Drug Quality | No |
| US-Canada Regional ICH Consultation | Webinar | 5/11/2022 | Clinical Trials and Research; International; New Drug Development | No |
| FDA Workshop on the Role of Phytosterols in PNALD/IFALD | Webinar | 5/6/2022 | Drug Development | No |
| Generic Drugs Forum 2022: The Current State of Generic Drugs | Conference/Workshop | 4/26/2022 | Generic Drug Development | No |
| The Key Elements of Being “Recall-Ready” | CDER SBIA Chronicles | 4/20/2022 | Recalls | No |
| The Key Elements of Being "Recall-Ready" | CDER SBIA Chronicles Podcast | 4/20/2022 | Recalls | No |
| Proposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers | Webinar | 4/13/2022 | DSCSA | No |
| FDA Inspections of Outsourcing Facilities | Webinar | 4/6/2022 | Compounding, Inspections | No |
| Immunogenicity Information in Labeling | Webinar | 4/5/2022 | Drug Development, Labeling | No |
| OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings | Webinar | 3/29/2022 | OTC Drug Regulation, Clinical Trials and Research, Regulatory Submissions, FDA Meetings/Communications | No |
| FDA-EMA Parallel Scientific Advice (PSA) Program | Webinar | 3/16/2022 | New Drug Development, Drug Development, International, Regulatory Submissions | No |
| Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA | Webinar | 2/24/2022 | Drug Development, Generic Drug Development | No |
| CDER BIMO GCP Compliance and Enforcement | Webinar | 2/16/2022 | Clinical Trials and Research, Inspections, New Drug Development | No |
| Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance | Webinar | 2/10/2022 | New Drug Development, Clinical Trials and Research, IND | No |
| Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics | Webinar | 1/27/2022 | New Drug Development, Labeling, Post Approval, Clinical Trials and Research | No |
| OTC Monograph Reform: Deemed Final Orders | Webinar | 12/15/2021 | OTC Drug Regulation | No |
| OTC Monograph Reform: OTC Sunscreen Drugs | Webinar | 12/15/2021 | OTC Drug Regulation | No |
| Clinical Investigator Training Course (CITC) Update | Webinar | 12/7/2021 | Clinical Trials and Research, New Drug Development | No |
| Pharmaceutical Quality Symposium 2021: Innovations in a Changing World | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 2, FDA Leaders Panel Discussion | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 3 Panel Questions and Discussion | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 4 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 5 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 6 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 7 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Pharmaceutical Quality Symposium 2021 Part 8 | Conference/Workshop | 10/26/2021 | Drug Quality | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 2 | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 3 | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 4 with Closing Remarks | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct | Conference/Workshop | 10/13/2021 | Registration and Listing | No |
| Webinar | 10/5/2021 | DSCSA | No | |
| Investigator Responsibilities — Safety Reporting for Investigational Drugs and Device | Webinar | 9/29/2021 | IND, Safety | No |
| Advancing Generic Drug Development: Translating Science to Approval | Conference/Workshop | 9/21/2021 | Generic Drug Development | No |
| Advancing Generic Drug Development: Translating Science to Approval Keynote Address | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| COVID-19 Impact on Generic Drug Regulation and Evaluation + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Considerations in Assessing Generic Drug Products of Oral Dosage Forms + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 1 + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 2 + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Advancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Cutting Edge Science in Complex Generics + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Nasal and Inhalation Products + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Topical Products, Part 1 + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Complex Generics_Topical Products, Part 2 + QA | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| Advancing Generic Drug Development: Translating Science to Approval, Day Two Closing Remarks | Conference/Workshop | 9/15/2021 | Generic Drug Development | No |
| The ABCs of Product Specific Guidances | CDER SBIA Chronicles | 9/2/2021 | Generic Drug Development | No |
| The ABCs of Product Specific Guidances | CDER SBIA Chronicles Podcast | 9/2/2021 | Generic Drug Development | No |
| Promotional Submissions in eCTD Format – Grouped Submissions | Webinar | 8/31/2021 | Regulatory Submissions | No |
| Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency | Webinar | 8/25/2021 | Inspections; Drug Quality; DSCSA | No |
| Regulatory Education for Industry (REdI) Annual Conference 2021 | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| 2021 REdI Conference Keynote Address by Janet Woodcock, MD | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| 2021 REdI Conference Plenary Session with Patrizia Cavazzoni, MD | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| OND Reorganization and the New Drugs Regulatory Program Modernization | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| ANDA Efforts Related to COVID-19 | Conference/Workshop | 7/19/2021 | Generic Drug Development | No |
| Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| CDER NextGen Portal | Conference/Workshop | 7/19/2021 | Regulatory Submissions | No |
| Electronic Common Technical Document (eCTD) | Conference/Workshop | 7/19/2021 | Regulatory Submissions | No |
| Product Quality Consideration for Emergency Use Authorizations (EUAs) | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| Strategies to Address Potential Medication Errors for EUA Products for COVID-19 | Conference/Workshop | 7/19/2021 | New Drug Development; Safety | No |
| Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| Where Do We Go from Here? How the Ombudsman Can Help | Conference/Workshop | 7/19/2021 | FDA Meetings/Communications | No |
| Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO | Conference/Workshop | 7/19/2021 | FDA Meetings/Communications | No |
| Communications in a Global Pandemic | Conference/Workshop | 7/19/2021 | FDA Meetings/Communications | No |
| Regulatory Policy: Role in Guiding Decision Making in CDER | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| Role of the Product Jurisdiction Team in the Medical Product Development Process | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency | Conference/Workshop | 7/19/2021 | New Drug Development; Clinical Trials and Research | No |
| OSI’s Role in the Drug Development Process and Impact of COVID-19 | Conference/Workshop | 7/19/2021 | New Drug Development | No |
| Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies | Webinar | 6/29/2021 | IND, Safety | No |
| Identification of Medicinal Products: Path to Global Implementation | Webinar | 6/11/2021 | International, Labeling, Regulatory Submissions | No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar | Webinar | 6/3/2021 | OTC Drug Regulation | No |
| FDA Study Data Technical Rejection Criteria (TRC): What you need to know! | Webinar | 5/21/2021 | Regulatory Submissions | No |
| FY 2021 Generic Drug Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Welcome, Keynote, and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Generic Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Public Comment - GDUFA Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Panel Discussion with Generic Industry - GDUFA Science and Research Initiatives Public Workshop | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Model-Integrated Evidence for Generic Drug Development – Session 1A | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Model-Integrated Evidence for Generic Drug Development – Session 1B | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Model-Integrated Evidence for Generic Drug Development – Session 1C | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Complex Product Characterization/Analysis - Session 2A | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Complex Product Characterization/Analysis - Session 2B | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Complex Product Characterization/Analysis - Session 2C | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| Closing Remarks - Robert Lioberger, PhD, Director, Office of Research and Standards (ORS), OGD, FDA | Conference/Workshop | 6/23/2021 | Generic Drug Development | No |
| FDA and Health Canada Regional ICH Consultation | Conference/Workshop | 5/14/2021 | Clinical Trials and Research; International; New Drug Development | No |
| FDA and Health Canada Regional ICH Consultation - Part I | Conference/Workshop | 5/14/2021 | Clinical Trials and Research; International; New Drug Development | No |
| FDA and Health Canada Regional ICH Consultation - Part II | Conference/Workshop | 5/14/2021 | Clinical Trials and Research; International; New Drug Development | No |
| Common Labeling Deficiencies and Tips for Generic Drug Applications | Webinar | 5/7/2021 | Generic Drug Development; Labeling | No |
| FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs | Webinar | 5/5/2021 | Generic Drug Development; New Drug Development; Orange Book | No |
| Generic Drugs Forum 2021: Lifecycle of a Generic Drug | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Generic Drugs Forum 2021: Lifecycle of a Generic Drug: Keynote from Sally Choe, Director, Office of Generic Drugs (OGD) | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Office of Pharmaceutical Quality (OPQ) Update | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Global Generic Drug Landscape | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Data Integrity Issues in Bioequivalence Studies | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Bioavailability/Bioequivalence Site Evaluation During the Pandemic | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Generic Drugs Forum 2021: Panel Discussion 1 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| OPQ Policy Update | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Update on CDER’s Quality Management Maturity Program | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Generic Drugs Forum 2021: Panel Discussion 2 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Pre-ANDA Program | Conference/Workshop | 4/28/2021 | Generic Drug Development; FDA Meetings/Communications | No |
| Pre-ANDA Program Update and Tips for Success – OPQ Perspective | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Controlled Correspondence Related to Pharmaceutical Quality | Conference/Workshop | 4/28/2021 | Generic Drug Development; FDA Meetings/Communications | No |
| Generic Drugs Forum 2021: Panel Discussion 3 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| >ANDA Labeling: Recommendations and Helpful Resources | Conference/Workshop | 4/28/2021 | Generic Drug Development; Labeling | No |
| Generic Drugs Forum 2021: Panel Discussion 4 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Addressing Common Challenges in BE Studies Due to COVID-19: OGD’s Approach | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Insights from Records Requests under §704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Generic Drugs Forum 2021: Panel Discussion 5 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Mid-Review Cycle Meeting Overview | Conference/Workshop | 4/28/2021 | Generic Drug Development; FDA Meetings/Communications | No |
| Information to Include with Cover Letters | Conference/Workshop | 4/28/2021 | Generic Drug Development; FDA Meetings/Communications | No |
| Application Communications – Quality Assessment Perspective | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Generic Drugs Forum 2021: Panel Discussion 6 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Fostering Innovation Through OPQ’s Emerging Technology Program | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Lab Science to Support Generic Complex Drug Product Assessment | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Assessment of Extractables/Leachables Data in ANDA Submissions | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Generic Drugs Forum 2021: Panel Discussion 7 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Integrated Manufacturing Assessment: Expectations | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Building a Better Sterility Assurance Application | Conference/Workshop | 4/28/2021 | Generic Drug Development; Drug Quality | No |
| Generic Drugs Forum 2021: Panel Discussion 8 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Postmarketing Safety and Surveillance of Generic Drugs Update | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies | Conference/Workshop | 4/28/2021 | Generic Drug Development; Safety | No |
| Update on Shared System REMS for Generic Drug | Conference/Workshop | 4/28/2021 | Generic Drug Development; Safety | No |
| ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Generic Drugs Forum 2021: Panel Discussion 9 | Conference/Workshop | 4/28/2021 | Generic Drug Development | No |
| Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop | Webinar | 4/9/2021 | Drug Master Files | No |
| FDA Safety Report Type Flag Requirement for FAERS Submissions | Webinar | 2/19/2021 | Regulatory Submissions; Safety | No |
| Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Innovation Mindset – Advancing Science to Therapies | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| FDA Oncology Drug Development Overview – Past to Present | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Federal Resources for Innovative Cancer Startups: More Than Just Funding | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Best Practices for Venture Capital Fundraising: Learn How Early-stage VCs Think | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Funding Sources Panel Discussion | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Building Your Network and Value to Obtain External Input Prior to Interacting with FDA | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Assembling the Best Team to Navigate through Preclinical Development | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Consulting Companies and FDA Limitations Panel Discussion | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| CMC Considerations for CAR T Cell Product Development | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| CMC Considerations for Oncolytic Viral Product Development | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Oncology Therapy Development Workshop Overview, Day Two | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it. | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| CMC Considerations for Biotechnology Product Development: A Regulatory Perspective | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Getting to First-in-Human for Small Molecules and Biologics | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Designing First-In-Human Trials for Small Molecules and Biologics | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Planning for Co-development of Companion Diagnostics | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Getting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop: Panel Discussion | Conference/Workshop | 3/30/2021 | New Drug Development; Clinical Trials and Research | No |
| Drug Master File (DMF) and Drug Substance Workshop | Webinar | 3/3/2021 | Drug Master Files | No |
| Regulatory Perspectives for Development of Drugs for Treatment of NASH | Webinar | 1/29/2021 | New Drug Development; Clinical Trials and Research | No |
| OTC Monograph Reform in the CARES Act: Safety Orders | Webinar | 1/27/2021 | OTC Drug Regulation | No |
| CDER Compliance Conference | Conference/Workshop | 1/14/2021 | Compliance, Import/Export; Compounding; DSCSA; Safety | No |
| Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter | Conference/Workshop | 1/14/2021 | Compliance, Import/Export; Compounding | No |
| Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates | Conference/Workshop | 1/14/2021 | Compliance, DSCSA | No |
| A Glance at Drug Importation Requirements | Conference/Workshop | 1/14/2021 | Compliance, Import/Export; Compounding | No |
| Risk Evaluation and Mitigation Strategies (REMS) Compliance Program | Conference/Workshop | 1/14/2021 | Compliance, Safety | No |
| Drug Master File (DMF) Submissions on New FDA Form 3938 | Webinar | 1/13/2021 | Drug Master File | No |
| Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA | Webinar | 12/16/2020 | Clinical Trials and Research | No |
| SEND for CBER, What You Need to Know | Webninar | 12/4/2020 | Regulatory Submissions | No |
| Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions | Webinar | 11/20/2020 | Generic Drug Development | No |
| Office of Prescription Drug Promotion - Core Launch Review Process | Webinar | 11/20/2020 | Marketing | No |
| Bridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients | Webinar | 11/13/2020 | Labeling | No |
| Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available | Webinar | 11/6/2020 | New Drug Development | No |
| Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Opening Remarks and FDA's Orange Book: A Historical Review of 40 Years | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book 101: An Overview of FDA's Orange Book | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| How to Update Orange Book Information | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| How to Update Orange Book Information – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| An Overview of FDA's Patent Listing Process | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Changes to Orange Book Patent Information | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Patent Information – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| The Patent Information Dispute Process | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Best Practices for 505(b)(2) and ANDA Applicants | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Patent Dispute and Best Practices for 505(b)(2) and ANDA Applicants – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity: An Introduction and Overview | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity: Part I - NCE and 3-Year | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity: Part III - 180-Day and Competitive Generic Therapy Exclusivities | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book Exclusivity – Panel Discussion | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book: An Overview of Therapeutic Equivalence | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Referencing Approved Drug Products in ANDA Submissions | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Orange Book: Looking Towards the Future | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| Closing Remarks | Conference/Workshop | 10/27/2020 | Generic Drug Development; New Drug Development; Orange Book | No |
| New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment | Webinar | 10/15/2020 | Drug Development; Clinical Trials and Research | No |
| Drug Registration and Listing Workshop | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: Labeler Code Request | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: Establishment Registration | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: Drug Listing | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: 503B Compounder Product Reporting Using CDERDirect | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Drug Registration and Listing Workshop: Establishment Registration and Drug Listing Compliance Program | Conference/Workshop | 10/8/2020 | Registration and Listing | No |
| Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs | Webinar | 10/2/2020 | Drug Quality | No |
| Advancing Innovative Science in Generic Drug Development Workshop | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Dr. Hahn's Remarks to “Advancing Innovative Science in Generic Drug Development” Workshop 9/29/2020 | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Update on GDUFA Science and Research | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| March 2020 Transition Under the BPCI Act: Impact on Generics | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Quantitative Methods for Determining Equivalence of Particle Size Distributions | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vitro Release Testing for Complex Generics: A Bioequivalence Perspective | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Development and Validation Considerations for Drug Release and Permeation Testing | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| What’s New in the Inactive Ingredient Database (IID)? | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Local Toxicity Considerations for Qualifying Excipients in Generic Drugs | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Excipient and Formulation Considerations | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| The Potential of PK BE Studies in Detecting Regional Deposition with Orally Inhaled Drugs | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Topical Dermatologic Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| PBPK to Guide Study Design and Product Development for Generic Dermatological Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Emerging Use of Modeling and Simulation for Bioequivalence | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Biopharmaceutics Classification System Class 3 Waiver | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Using PBPK Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| A Closer Look into the Nasogastric and Gastric Feeding Tube Study Recommendations | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| In Vitro Enteral (Nasogastric and Gastric) Feeding Tube Testing of Generic Drugs: Case Studies | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Practical Considerations for Bioequivalence of GI Locally-Acting Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Panel on In Vitro Feeding Tube Testing and GI Locally-Acting Products | Conference/Workshop | 9/29/2020 | Generic Drug Development | No |
| Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations | Webinar | 9/16/2020 | Drug Master Files | No |
| Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; Real World Evidence; Postapproval | No |
| Restructure of the Office of New Drugs (OND) - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval | No |
| So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval | No |
| Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Safety | No |
| Drug Shortages - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Shortages | No |
| Enhanced Drug Distribution Security – DSCSA Implementation Updates - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; DSCSA | No |
| CDER Export Certificate Program - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Import/Export | No |
| SBIA Program Overview - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Resources | No |
| Post-Approval Submission of Promotional Materials to the OPDP - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Marketing | No |
| Requirement for Electronic Submission of an Application and Study Data - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Regulatory Submissions | No |
| Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Quality | No |
| Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Quality | No |
| Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Quality | No |
| Questions and Panel Discussion – Post-approval CMC and Manufacturing - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Drug Quality | No |
| FDA Drug Manufacturing Inspections - REdI 2020 | Conference/Workshop | 8/25/2020 | New Drug Development; NDA; Postapproval; Inspections | No |
| Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA | Webinar | 12/18/2017 | Generic Drug Development; Regulatory Submissions | No |
| Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions | Webinar | 3/6/2017 | Generic Drug Development | No |
Program Overview