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 on our SBIA Spanish Captions YouTube playlist. Ahora se tienen subtítulos en español para módulos de capacitación seleccionados en nuestra lista de reproducción en español en YouTube.
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| Summary | Type | Issued/Updated | Topic |
|---|---|---|---|
| Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs | Workshop | 8/27/2026 | Generic Drug Development, ANDA |
| What to Expect after an Inspection: 483s, Responses and Beyond (meeting materials) Video | Webinar | 12/14/2022 | Compliance, Compounding, Inspections, FDA Form 483 |
| FDA Inspections of Outsourcing Facilities | Webinar | 4/6/2022 | Compounding, Inspections |
| FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates | Conference | 9/29/2026 | International, Import/Export, National Drug Code, Registration and Listing |
| Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications | On Demand | 6/23/2026 | New Drug Development, Safety Evaluation |
| Office of New Drugs Custom Medical Queries (OCMQs) for Safety Signal Detection in Clinical Trial Data | On Demand | 6/23/2026 | New Drug Development, Safety Evaluation |
| Panel One - ClinicalTrials.gov: Essentials for Academic Medical Centers | Webinar | 7/14/2026 | Clinical Trials and Research; Electronic Submissions; New Drug Development |
| Panel Two - ClinicalTrials.gov: Essentials for Academic Medical Centers | Webinar | 7/22/2026 | Clinical Trials and Research; Electronic Submissions; New Drug Development |
| Panel Three - ClinicalTrials.gov: Essentials for Academic Medical Centers | Webinar | 7/30/2026 | Clinical Trials and Research; Electronic Submissions; New Drug Development |
| Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations | Workshop | 6/11/2026 | ANDA, Bioequivalence, Generic Drug Development, Oral Generic Drug Products |
| Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products | Conference | 5/19/2026 | Advanced Manufacturing, Artificial Intelligence, Biologics, Clinical Trials and Research, Combination Products, Devices, Drug Safety, Drug Supply Chain, Electronic Submissions, Inspections, New Drug Development |
| OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration | Webinar | 5/5/2026 | OTC Drug Regulation, Registration and Listing, User Fees |
| FDA's Participation in USP-NF Revision Process – Challenges and Solutions | On Demand | 12/11/2025 | Drug Development; Drug Quality; Manufacturing, USP Standards |
| Strengthening Your Compendial Strategy | On Demand | 12/11/2025 | Drug Development; Drug Quality; Manufacturing, USP Standards |
| Industry’s Engagement in USP’s Standards-Setting Process | On Demand | 12/11/2025 | Drug Development; Drug Quality; Manufacturing, USP Standards |
| Quality and Regulatory Predictability: Shaping USP Standards – Q&A Discussion Panel | On Demand | 12/11/2025 | Drug Development; Drug Quality; Manufacturing, USP Standards |
| 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 |
| Certificates of Confidentiality Part 1: General Overview | On Demand | 5/7/2025 | BLA; Clinical Trials and Research; Devices; Drug Development; NDA; New Drug Development |
| 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 |
| 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 |
| Generic Drugs Forum (GDF) 2025: Office of Generic Drugs (OGD) Keynote | On Demand | 4/9/2025 | ANDA; Bioequivalence; Generic Drug Development |
| Generic Drugs Forum (GDF) 2025: Office of Pharmaceutical Quality (OPQ) Keynote | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality |
| ANDA Missed Goal Dates: An Update on Metrics and Internal Communications | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Meetings; FDA Meetings/Communications |
| Request for Reconsideration_Process Overview and Best Practices for FDA Evaluation | On Demand | 4/9/2025 | ANDA; Generic Drug Development |
| Request for Reconsideration Under GDUFA III – Overview and Experience from BE Perspectives | On Demand | 4/9/2025 | ANDA; Bioequivalence; Generic Drug Development |
| 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 |
| Best Practices for Generic Drug Labeling | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Labeling |
| Project Managing Drug Assessors Under GDUFA III Regulations | On Demand | 4/9/2025 | ANDA; Generic Drug Development |
| Minor Regulatory Errors with Major Consequences | On Demand | 4/9/2025 | ANDA; Generic Drug Development |
| 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 |
| Considerations when Submitting Proposed Excipient Levels in Inactive Ingredient Controlled Correspondences | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality |
| Building a Global Framework for Assessing Inactive Ingredients in Generic Drug Applications | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality |
| How to Leverage the Inactive Ingredient Database and Justify Excipient Safety in ANDAs | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 1 Session 3 | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality |
| Product Specific Guidance (PSG) Program Overview | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence |
| Pre-Abbreviated New Drug Application (ANDA) Meetings: Process and Best Practices | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Meetings; FDA Meetings/Communications |
| Experiences from Post-Complete Response Letter Scientific Meetings in GDUFA III | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Meetings; FDA Meetings/Communications |
| Common Discrepancies Observed on the Form 356h with the ANDA Submission | On Demand | 4/9/2025 | ANDA; Generic Drug Development |
| 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 |
| General Quality Considerations of Drug Products Labeled for Alternate Dosing Administration | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality |
| Nitrosamine Related Guidance | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality |
| Bioequivalence Approaches for Nitrosamine Impacted ANDA Applications: Case Studies | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality; Bioequivalence |
| 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 |
| 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 |
| Analysis of Common ANDA Major Deficiencies | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence |
| CommonBioequivalence Deficiencies in Abbreviated New Drug Applications for Extended-Release Drug Products | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence |
| Common Clinical Deficiencies in Abbreviated New Drug Applications (ANDAs) Containing Comparative Clinical Endpoint Studies | On Demand | 4/9/2025 | ANDA; Generic Drug Development |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 2 Session 2 | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality; Bioequivalence |
| GDUFA III Impact on Drug Master File (DMF) Assessment | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Drug Master Files |
| Common Deficiencies in Drug Master Files (DMFs) | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Drug Master Files |
| Common (OPQ) Deficiencies in Abbreviated New Drug Applications (ANDAs) | On Demand | 4/9/2025 | ANDA; Generic Drug Development |
| 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 |
| 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 |
| Orange Book Drug Marketing Status | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence |
| 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 |
| Common Bioequivalence (BE) Information Requests (IRs): Tips for Facilitating the Review Process | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence |
| Generic Drugs Forum (GDF) 2025: Questions & Panel Discussion - Day 2 Session 4 | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Bioequivalence |
| Generic Drugs Forum (GDF) 2025: Closing Remarks | On Demand | 4/9/2025 | ANDA; Generic Drug Development; Pharmaceutical Quality; Bioequivalence |
| Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions | On Demand | 3/13/2025 | Model Master Files |
| Navigating Controlled Correspondences to Support Generic Drug Development | On Demand | 2/27/2025 | ANDA; Controlled Correspondence; Generic Drug Development; Regulatory Submissions |
| BsUFA III Regulatory Science Pilot Program: Progress Update | On Demand | 1/22/2025 | BLA; Biologics; Biosimilars; International; Regulatory Science |
| 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 |
| FDA Structure and Mandate | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development |
| Basics of Clinical Trial Design | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development |
| Statistical Principles for Clinical Development | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Statistical Analysis |
| 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 |
| Safety Considerations in Clinical Drug Development | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Safety |
| Specific Populations in Clinical Trials | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development |
| 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 |
| 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 |
| Pharmacology & Toxicology in the Investigator’s Brochure | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Safety; IND |
| Clinical Pharmacology: Early Drug Development | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Safety; IND |
| 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 |
| Innovative Approaches to Clinical Trials | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Real World Evidence; Digital Health Technologies |
| Informed Consent: More than just a document | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Good Clinical Practice |
| 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 |
| mRNA Vaccines | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Vaccines; Biologics |
| Innovative Therapeutics: Gene Therapy | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Biologics |
| 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 |
| 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 |
| 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 |
| International Clinical Trials | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; International |
| 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 |
| 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 |
| Clinical Investigator Inspection Readiness | On Demand | 12/10/2024 | Clinical Trials and Research; New Drug Development; Inspections |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Quality Considerations for First Generic Oral Liquids | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment |
| 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 |
| 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 |
| 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 |
| 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 |
| Emerging Generic Oligonucleotides -Challenges and Progress | On Demand | 9/24/2024 | ANDA; Complex Generic Drug; Product Specific Guidances; Generic Drug Development; Regulatory Assessment |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Advancing Generic Drug Development: Translating Science to Approval 2024 - Closing Remarks | On Demand | 9/24/2024 | Registration and Listing |
| Public Health Impact of Registration and Listing Data | On Demand | 9/12/2024 | Registration and Listing |
| CDER Direct Establishment Registration Demo | On Demand | 9/12/2024 | Registration and Listing |
| Establishment Registration Highlights | On Demand | 9/12/2024 | Registration and Listing |
| Complying with Establishment Registration Requirements | On Demand | 9/12/2024 | Registration and Listing |
| CDER Direct Labeler Code Request Demo | On Demand | 9/12/2024 | Registration and Listing |
| Labeler Code Request Highlights | On Demand | 9/12/2024 | Registration and Listing |
| Complying with Labeler Code Request Requirements | On Demand | 9/12/2024 | Registration and Listing |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 - Q&A Discussion Panel 1 | On Demand | 9/12/2024 | Registration and Listing |
| CDER Direct Drug Listing | On Demand | 9/12/2024 | Registration and Listing |
| Listing Updates and Blanket “No Changes” Certification Demo | On Demand | 9/12/2024 | Registration and Listing |
| Drug Listing Highlights | On Demand | 9/12/2024 | Registration and Listing |
| Complying with Drug Listing Requirements | On Demand | 9/12/2024 | Registration and Listing |
| NDC Reservation | On Demand | 9/12/2024 | Registration and Listing |
| Future Format of the National Drug Code | On Demand | 9/12/2024 | Registration and Listing |
| NDC Assignment to Drugs | On Demand | 9/12/2024 | Registration and Listing |
| OTC Drug Listing Updates and Validation | On Demand | 9/12/2024 | Registration and Listing |
| Drug Amount Reporting for Listed Drugs | On Demand | 9/12/2024 | Registration and Listing |
| Who Should Not Register or List | On Demand | 9/12/2024 | Registration and Listing |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 - Case Studies | On Demand | 9/12/2024 | Registration and Listing |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 - Q&A Discussion Panel 2 | On Demand | 9/12/2024 | Registration and Listing |
| 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 |
| Overview of CDER’s Small Business & Industry Assistance (SBIA) | On Demand | 9/4/2024 | New Drug Development; FDA Meetings/Communications; Drug Development |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Selective Safety Data Collection in Clinical Trials | On Demand | 5/29/2024 | Clinical Trials and Research; Drug Safety; New Drug Development |
| The CDER Center for Clinical Trial Innovation (C3TI) | On Demand | 5/29/2024 | Artificial Intelligence; Clinical Trials and Research; New Drug Development |
| Responsive Regulation of Artificial Intelligence in Drug Development | On Demand | 5/29/2024 | Advanced Manufacturing; Artificial Intelligence; Clinical Trials and Research; New Drug Development |
| ClinicalTrials.gov: Meeting Transparency and Reporting Requirements | On Demand | 5/29/2024 | Clinical Trials and Research; Electronic Submissions; New Drug Development |
| Diversity in Clinical Trials: Drug Trials Snapshots Perspective | On Demand | 5/29/2024 | Artificial Intelligence; Clinical Trials and Research; New Drug Development |
| Combination Products: Updates and Best Practices | On Demand | 5/29/2024 | Combination Products; New Drug Development |
| Leveraging Small Business and Industry Assistance (SBIA) Resources | On Demand | 5/29/2024 | New Drug Development; FDA Meetings/Communications |
| Improving Informed Consent | On Demand | 5/29/2024 | Clinical Trials and Research; Good Clinical Practice; New Drug Development |
| 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 |
| ECTD v4.0 Implementation Update | On Demand | 5/29/2024 | Electronic Submissions; New Drug Development |
| FDA CDER NextGen Portal | On Demand | 5/29/2024 | Electronic Submissions; New Drug Development |
| 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 |
| FDA Electronic Submission Gateway – Next Generation (NextGen) | On Demand | 5/29/2024 | Electronic Submissions; New Drug Development |
| 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 |
| 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 |
| 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 |
| The Advanced Manufacturing Technologies Designation Program | On Demand | 5/29/2024 | Advanced Manufacturing; Artificial Intelligence; Clinical Trials and Research; New Drug Development |
| Compliance Approaches to Emerging Threats | On Demand | 5/29/2024 | Clinical Trials and Research; New Drug Development |
| 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 |
| Key Components to Assure Pharmaceutical Quality | On Demand | 4/10/2024 | ANDA; Bioequivalence; Chemistry Manufacturing and Controls (CMC); Pharmaceutical Quality |
| FDA’s Role in Preventing and Mitigating Drug Shortages | On Demand | 4/10/2024 | ANDA; Drug Shortages |
| GDUFA III Policy Accomplishments | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Pharmaceutical Quality |
| GDUFA III Suitability Petitions | On Demand | 4/10/2024 | ANDA; Bioequivalence; Generic Drug Development; |
| Overview of the FDA Product-Specific Guidance (PSG) Program | On Demand | 4/10/2024 | ANDA; Bioequivalence; Generic Drug Development; |
| 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 |
| 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 |
| Overview of Quality-Related Controlled Correspondence (CC) | On Demand | 4/10/2024 | ANDA; Controlled Correspondence; Generic Drug Development; Meetings; FDA Meetings/Communications |
| Overview and Considerations of Pre-ANDA Scientific Meetings Under GDUFA III | On Demand | 4/10/2024 | ANDA; FDA Meetings/Communications; Generic Drug Development; Meetings |
| 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 |
| 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 |
| ANDA Program Statistics | On Demand | 4/10/2024 | ANDA; Generic Drug Development |
| ANDA Project Management Topics: PLAIR and Cover Letter Attachments | On Demand | 4/10/2024 | ANDA; Generic Drug Development; FDA Meetings/Communications; Regulatory Submissions |
| 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 |
| 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 |
| Pediatric Excipient Evaluation: BE Perspective | On Demand | 4/10/2024 | ANDA; Bioequivalence; Generic Drug Development; Pediatric |
| GDSA-BE: Modernizing Bioequivalence Assessment for Abbreviated New Drug... | On Demand | 4/10/2024 | ANDA; Bioequivalence; Generic Drug Development |
| 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 |
| Comparative Analyses Update | On Demand | 4/10/2024 | ANDA; Drug Safety; Generic Drug Development; Regulatory Submissions |
| Successful Practices for Pharmacology/Toxicology Justification in ANDAs | On Demand | 4/10/2024 | ANDA; Drug Safety; Generic Drug Development; Regulatory Submissions |
| 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 |
| Nitrosamine Risk Assessment in Type II DMFs Supporting GDUFA Applications | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Drug Master File; Pharmaceutical Quality |
| 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 |
| 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 |
| 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 |
| 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 |
| Facility Assessment for Pre-Marketing Applications: Inspections and Remote Regulatory Assessments | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Pharmaceutical Quality; Inspections |
| GDUFA-III Implementation –Facility Related Updates | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Pharmaceutical Quality; Inspections |
| 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 |
| 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 |
| 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 |
| 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 |
| ANDAs Labeling Requirements for Rx to OTC Switched Products | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Labeling; OTC Drug Regulation; Regulatory Submissions |
| Regulatory Reminders to the Finish Line | On Demand | 4/10/2024 | ANDA; Generic Drug Development; Regulatory Submissions |
| 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 |
| 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 |
| 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 |
| 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 |
| Technology in Clinical Trials- Digital Health Technology (DHT) | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Digital Health Technologies |
| 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 |
| Good Data Governance Practice Updates | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Regulatory Assessment |
| 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 |
| 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 |
| 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 |
| Sponsor Oversight in Clinical Trials | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Regulatory Assessment |
| 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 |
| The Future of GCP Inspections | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Good Clinical Practice; Regulatory Assessment; Inspections |
| Agency Updates: Policies, Guidances, and Initiatives | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Good Clinical Practice; Regulatory Assessment; Inspections |
| 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 |
| 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 |
| 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 |
| 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 |
| Bioequivalence: Remote Evaluations | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; International; Regulatory Assessment; Inspections |
| Bioequivalence: Bioanalytical Issues | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; ANDA; Bioequivalence; International; Regulatory Assessment; Inspections |
| 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 |
| Bioequivalence: Clinical Study Conduct | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; Good Clinical Practice; International; Regulatory Assessment; Inspections |
| 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 |
| Pharmacovigilance Compliance | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections; Safety |
| Pharmacovilgilance: International Collaboration | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections; Safety |
| Pharmacovilgilance: Future of Inspections | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections; Safety |
| Pharmacovilgilance: Regulatory Updates | On Demand | 2/13/2024 | New Drug Development; Clinical Trials and Research; International; Regulatory Assessment; Inspections; Safety |
| 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 |
| 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 |
| 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 |
| ICH Overview | On Demand | 2/22/2024 | International; New Drug Development; Generic Drug Development; Safety; Real Word Evidence; Analytical Validation; Drug Safety; Data Management |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Generic Drugs Forum (GDF) 2026 | Conference | 4/22/2026 | ANDA, Bioequivalence, Controlled Correspondence, Generic Drug Development, Manufacturing, Pharmaceutical Quality, Product Specific Guidances |
| Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers | Webinar | 4/15/2026 | Expanded Access, IND, Regulatory Submissions |
| Quality and Regulatory Predictability: Shaping USP Standards | Webinar | 12/11/2025 | Drug Development, Drug Quality, Manufacturing, USP Standards, |
| FDA Electronic Drug Registration and Listing (eDRLS) using CDER Direct Training Modules | On Demand | 7/24/2025 | Import/Export, International, Registration and Listing |
| FDA Pharmaceutical Quality Training Modules | On Demand | 7/24/2025 | Drug Quality, Quality Assessments, Supply Chain, Manufacturing, Emerging Technology, Generic Drug Development |
| 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 |
| 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 |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration | Webinar | 5/20/2025 | OTC Drug Regulation, User Fees |
| FDA CDER Overview: Certificates of Confidentiality | On Demand | 5/07/2025 | BLA, Clinical Trials and Research, Devices, Drug Development, NDA, New Drug Development |
| 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 |
| Navigating Controlled Correspondences to Support Generic Drug Development | Webinar | 2/27/2025 | ANDA, Controlled Correspondence, Generic Drug Development, Regulatory Submissions |
| 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 |
| Improving Data Quality with Centralized Statistical Monitoring with Dr. Paul Schuette and Xiaofeng (Tina) Wang | SBIA Chronicles Podcast | 12/13/2024 | Statistical Analysis |
| Generic Drugs Forum (GDF) 2025 | Conference | 4/9/2025 | ANDA, Bioequivalence, Generic Drug Development |
| BsUFA III Regulatory Science Pilot Program: Progress Update | Webinar | 1/22/2025 | BLA; Biologics; Biosimilars; International; Regulatory Science |
| 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 |
| 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 |
| M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance | Webinar | 11/21/2024 | ANDA, Bioequivalence, Generic Drug Development, International |
| The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball | SBIA Chronicles Podcast | 11/14/2024 | Artificial Intelligence |
| 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 |
| 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) |
| Global IDMP Implementation - Getting Closer to the Goal | Webinar | 10/16/2024 | Data Standards, Drug Shortages, Labeling, Electronic Submissions, Pharmacovigilance, Regulatory Submissions |
| ICH M12 Drug-Drug Interaction Studies Final Guidance | Webinar | 10/9/2024 | Drug Interaction, New Drug Development, IND |
| 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 |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 | Conference/Workshop | 9/12/2024 | Import/Export, International, Registration and Listing |
| ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA | Webinar | 9/10/2024 | ANDA, Generic Drug Development, Regulatory Submissions |
| 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 |
| Environmental Monitoring in Compounding | Webinar | 7/30/2024 | Compounding, Environmental Monitoring, Outsourcing Facilities |
| Dataset-JSON Pilot Report and Next Steps | Webinar | 7/25/2024 | Data Standards, International, Regulatory Science, Regulatory Submissions |
| Introduction to FDA’s Office of Trade and Global Partnerships | Webinar | 7/23/2024 | Combination Products, Drug Supply, International Trade |
| Office of Pharmaceutical Quality (OPQ) Reorganization | On Demand | 7/16/2024 | Drug Quality, Emerging Technology, International, Manufacturing, Quality Assessments, Supply Chain |
| Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule | Webinar | 6/26/2024 | Advertising, Marketing, Regulatory Submissions |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration | Webinar | 6/18/2024 | OTC Regulation, User Fees |
| 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 |
| 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 |
| Considerations for Drug Products that Contain Nanomaterials | SBIA Chronicles Podcast | 5/17/2024 | Nanomaterials |
| Considerations for Drug Products that Contain Nanomaterials | SBIA Chronicles | 5/17/2024 | Nanomaterials |
| Statistical Considerations for Premarketing Risk Assessment | Webinar | 5/16/2024 | Clinical Trials and Research, New Drug Development, Integrated Safety Analyses |
| Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval | Webinar | 5/9/2024 | ANDA, Generic Drug Development, Meetings, Regulatory Assessments |
| Facilitating Generic Drug Product Development through Product-Specific Guidances | Webinar | 4/25/2024 | ANDA, Bioequivalence, Generic Drug Development, Product Specific Guidances |
| 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 |
| Expanding Generic Drug Access Through International Engagements | Webinar | 2/28/2024 | ANDA, Bioequivalence, Clinical Trials and Research, Complex Generic Drug, Generic Drug Development, International |
| Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes | Webinar | 3/7/2024 | Clinical Trials and Research, New Drug Development, Integrated Safety Analyses |
| 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 |
| 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 |
| 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 |
| Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources | Webinar | 12/12/2023 | IND, Labeling, Drug Interaction, Therapeutic Protein |
| 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 |
| Toward Global IDMP Implementation: A Focus on Global Use Cases | Webinar | 11/28/2023 | Regulatory Submissions, Data Standards |
| Common Issues with SEND Data Submitted for Safety Pharmacology Studies | Webinar | 11/16/2023 | Regulatory Submissions, Data Standards |
| Implementing DSCSA: Stabilization Period and Expectations | Webinar | 11/3/2023 | DCSA, Compliance, Drug Supply Chain, Wholesaler, Distributor, Unique Serial Numbers |
| Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing | Symposium | 10/31/2023 | Drug Quality, Quality Assessments, Supply Chain, Manufacturing, Emerging Technology |
| BsUFA III Regulatory Science Pilot Program | Webinar | 10/16/2023 | Biomarkers, Regulatory Science, BLA, Biologics |
| 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 |
| Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023 | Conference/Workshop | 9/28/2023 | Registration and Listing, Import/Export |
| 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 |
| 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 |
| Understanding FDA Inspections and Data | Webinar | 9/6/2023 | Inspections, International, Current Good Manufacturing Practice (CGMP) |
| OTC Monograph Reform: OMOR Format and Content & Electronic Submissions | Webinar | 8/22/2023 | OTC Drug Regulation, Regulatory Submissions, ANDA, NDA, New Drug Development |
Archived Resources
Access archived CDER Small Business and Industry Assistance (SBIA) Learn materials.