CDER SBIA Learn
Welcome to CDER SBIA Learn. We offer a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry. Our offerings are organized by topic below.
- User Fees and the Future of the OTC Monograph System (7/6/16): CDER SBIA Chronicles
- User Fees and the Future of the OTC Monograph System (7/6/16): CDER SBIA Chronicles Podcast [MP3]
- Bringing an Over-the-Counter Drug to Market: CDERLearn Course
- Time and Extent Applications for Nonprescription Drug Products (4/16/12): Webinar [ARCHIVED]
- Sunscreens Marketed Under the OTC Monograph System (9/19/11): Webinar [ARCHIVED]
Overview
- Best Practices for Communication Between FDA and IND Sponsors During Drug Development: CDERLearn course
- FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond: CDERLearn Course
- Case Studies in FDA’s Drug Regulatory Processes: CDERLearn Courses
- Drug, Not a Drug, or More? (9/17/15): CDER SBIA Chronicles
- CDER 101 (3/14/11): Webinar [ARCHIVED]
- A Primer for Understanding the Drug Development Process (10/2010): Slides
Investigational New Drug Application (IND)
FDA Insights on Products for Rare Diseases and Pediatrics (REdI Spring 2016): Slides/Recording
- Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND: CDERLearn Course
- Draft Guidance for Industry on Safety Assessment for IND Safety Reporting (2/1/16): Webinar
- Botanical Drug Review (11/17/15): CDER SBIA Chronicles
- Pediatric Drug Development: Regulatory Expectations (REdI Fall 2015): Slides
- Overview of FDA Expedited Programs with a Focus on the Breakthrough Therapy (RedI Fall 2015): Slides
- CDER Regulatory Applications – INDs and NDAs (REdI Spring 2015): Slides
- Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an IND (REdI Spring 2015): Slides
- Pediatric Drug Development: Regulatory Expectations – BASIC (REdI Fall 2014): Slides
- Pediatric Drug Development: Regulatory Expectations - INTERMEDIATE (REdI Fall 2014): Slides
- CDER Regulatory Applications – IND and NDA - Part 1 (REdI Fall 2014): Slides
- CDER Regulatory Applications – IND and NDA - Part 2 (REdI Fall 2014): Slides
- Enrichment Strategies (3/14/13): CDER SBIA Chronicles
- Breakthrough Therapies (1/15/13): CDER SBIA Chronicles
- Orphan Drugs (7/13/12): CDER SBIA Chronicles
- IND 101 (5/10/12): CDER SBIA Chronicles
- Office of Orphan Products Development: Incentives for Rare Diseases (10/18/11): Webinar [ARCHIVED]
- Rare Diseases Clinical Development at CDER (10/18/10): Slides [ARCHIVED]
Clinical Trials
- FDA's Role in ClinicalTrials.gov (REdI Spring 2016): Slides
- Increasing the Quality and Efficacy of Clinical Trials: The Clinical Trials Transformation Initiative (CTTI) (REdI Spring 2016): Slides/Recording
- Pilot Clinical Outcome Assessment Compendium (3/8/16): Webinar
- Clinical Outcome Assessment Implementation in Clinical Trials (REdI Fall 2015): Slides
- Use of Electronic Records and Signatures in Clinical Trials (REdI Fall 2015): Slides
- Source Data Capture from Electronic Health Records: Using Standardized Clinical Research Data (7/7/15): Webinar
- Good Clinical Practice (GCP) Update (9/2011): Slides
- The Genesis of the Human Subject Protections Regulations (9/2011): Slides
- Principles and applications of pharmacokinetics in Drug Development (9/2011): Slides
- Electronic Source Documentation in Clinical Investigations (9/2011): Slides
- Effective and Efficient Oversight of Clinical Investigations (9/2011): Slides
- Good Clinical Practice (GCP) Roles, Responsibilities and Inspections (9/2011) - Slides
- Clinical Trial Design (9/2011): Slides
- Pharmacokinetics in Clinical Trials (Clinical Trials Forum 4/2011): Slides
- Clinical Trial Design (Clinical Trials Forum 4/2011): Slides
- Electronic Source Documentation in Clinical Investigations (Clinical Trials Forum 4/2011): Slides
New Drug Application (NDA)
- Prescribing Information: Resources, Review Process, and Guidances Under Development (REdl Fall 2016): Slides/Recording
- Prescription Drug Labeling, Challenges and Issues: REdI Conference (11/2015): Slides
- Lifecycle Management of Drug Products: FDA’s Perspective (REdI Fall 2015): Slides
- Safety Considerations and Best Practices in Developing Proprietary Names for Drugs (REdI Fall 2015): Slides
- Lifecycle Management of Drug Products (REdI Spring 2015): Slides
- Evidence and Data Requirements for NDA Submissions (REdI Spring 2015): Slides
- CDER Regulatory Applications: IND and NDAs (REdI Spring 2015): Slides
- PDUFA V (10/12/12): CDER SBIA Chronicles
- Unapproved Universe (8/7/12): CDER SBIA Chronicles
- PDUFA (12/19/11): Webinar [ARCHIVED]
Communicating with FDA
- Best Practices for Communication Between IND Sponsors and FDA during Drug Development (REdI Spring 2016): Slides/Recording
- Interactions with the FDA - Why, When, and How (REdI Spring 2016): Slides
- Emerging Technology Team: FDA's Tool to Facilitate and Promote Pharmaceutical Innovation (REdI Spring 2016): Slides/Recording
- Engaging with the FDA During New Drug Development: CDERLearn Course
- Best Communication Practices with FDA (1/21/15): CDER SBIA Chronicles
- A Primer on Formal Meetings and Best Practices (REdI Fall 2015): Slides
- How to Prepare for a Successful Meeting With CDER (REdI Fall 2014): Slides
- Communicating with CDER (11/14/13): CDER SBIA Chronicles
- Beyond Guidance: Formal Meetings and Requests for Information (REdl Fall 2016): Slides/Recording
- Meetings with FDA (IND Process Workshop 10/8/10): Slides [ARCHIVED]
Safety
- Submitting Risk Evaluation and Mitigation Strategies (REMS) in Structured Product Labeling (SPL) Format (8/24/16): Webinar
- Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER (REdI Spring 2016): Slides/Recording
- Comparing Safety Report Requirements for Pre and Post Market (REdI Fall 2015): Slides
- Risk Evaluation and Mitigation Strategies: Modifications and Revisions (4/7/15): Webinar
- Drugs in Pregnancy and Lactation: Improved Benefit-Risk Information (1/22/15): CDER SBIA Chronicles
- Safety Labeling Changes for Prescription Drugs (9/20/13): CDER SBIA Chronicles
- FDAs Medical Countermeasures Initiative (MCMi) and You (3/19/12): Webinar [ARCHIVED]
Biologics and Biosimilars
- Patents and Exclusivity (5/19/15): CDER SBIA Chronicles
- The Purple Book (11/18/14): CDER SBIA Chronicles
- The Immunogenicity of Therapeutic Proteins (REdI Fall 2014): Slides
- BsUFA (5/21/13): CDER SBIA Chronicles
Other
Electronic Common Technical Document (eCTD) and Electronic Submissions Gateway (ESG)
- FDA Requires Use of eCTD Format and Standardized Study Data in Future Regulatory Submissions (09/22/2016): CDER SBIA Chronicales
- FDA Requires Use of eCTD Format and Standardized Study Data in Future Regulatory Submissions (09/22/2016): CDER SBIA Chronicles Podcast [MP3]
- Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria (10/12/16): Webinar
- Electronic Common Technical Document (eCTD): CDERLearn Course
- Required Electronic Submissions: eCTD and Study Data (10/8/15): Webinar
- FDA Electronic Submissions Gateway (REdI Fall 2014): Slides
- Go Green: Submit Electronically (6/14/12): CDER SBIA Chronicles
- Electronic Submissions Gateway (9/2011): Slides
- Electronic Submissions and the Electronic Common Technical Document (9/2011): Slides
- FDA Electronic Submissions Gateway (8/16/11): Webinar
Forms
- Generic Drugs Forum: REdI Conference (April 2017): Slides and Recordings
- Emerging Technology for Bioequivalence Evaluation of Locally Acting Nasal Sprays (5/19/16): CDER SBIA Chronicles
- Emerging Technology for Bioequivalence Evaluation of Locally Acting Nasal Sprays (5/19/16): CDER SBIA Chronicles [MP3]
Abbreviated New Drug Applications (ANDA) Submissions
- Electronic Submission Requirements for ANDAs: Are You Ready? (11/21/16): Webinar
- Generic Drugs Forum: REdl Conference (April 2015): Slides
- Refuse-to-Receive Standards and ANDA Submissions (9/16/14): Webinar
- Amendments and Easily Correctable Deficiencies Under GDUFA (7/10/14): Webinar
- Prior Approval Supplements Under GDUFA (7/10/14): Webinar
- Content and Format of Abbreviated New Drug Applications (6/12/14): Webinar
- Refuse-to-receive Standards (11/18/13): Webinar
- Stability Guidance for ANDAs, and draft Questions and Answers (11/4/13): Webinar
Generic Drug User Fee Amendments (GDUFA)
- FDA Addresses Small Business Concerns in GDUFA II (1/26/2017): CDER SBIA Chronicles and Audio Podcast
- Overview of GDUFA II and Implementation of GDUFA II User Fees (10/28/16): Webinar
- Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA): CDERLearn Course
- GDUFA Self-Identification (SPL) Submission – Part 1: CDERLearn Course
- GDUFA Self-Identification (SPL) Submission – Part 2: CDERLearn Course
- GDUFA and You Conference (March 2014): Slides
- GDUFA: Where Are We Now? (3/21/14): CDER SBIA Chronicles
- 2013 GDUFA and You Conference (June 2013): Slides
- DMFs under GDUFA (2/11/13): Webinar
- GDUFA: Self-identification Requirement - Discussion and Demonstration (Nov 2012): Webinar [ARCHIVED]
- GDUFA (11/16/12): CDER SBIA Chronicles
- GDUFA: User Fees and More (10/22/12): Webinar [ARCHIVED]
Communications with FDA
- Establishment Registration and Listing for Human Drugs: Webinar
- CDER Direct Electronic Submission Portal: 503B Product Reporting (Compounding): Webinar
- CDER Direct: Wholesale Drug Distributors and Third-Party Logistics Providers (12/14/15): Webinar
- A Demonstration of Product Listing in CDER Direct (10/5/15): Webinar
- A Demonstration of Establishment Registration in CDER Direct (9/9/15): Webinar
- How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files (9/16/14): Webinar
- Registration and Drug Listing (9/11/14): CDER SBIA Chronicles
- Electronic Drug Registration and Listing (eDRLS) (9/2011): Slides
- The Drug Supply Chain Security Act (DSCSA): Implementation Updates (REdI Spring 2016): Slides/Recording
- Annual Reporting by Rx Drug Wholesale Distributors and Third-Party Logistics Providers (12/16/14): Webinar
- Drug Supply Chain Security Act: Identification of Suspect Product and Notification (7/1/14): Webinar
- The Drug Supply Chain Security Act (3/12/14): Webinar
- Improving Drug Supply Chain Integrity (1/22/14): CDER SBIA Chronicles
- ACE/ITDS: FDA Implementation Update and Tips for Drug Importers (REdl Fall 2016): Slides/Recording
- Import-Export (7/14/15): CDER SBIA Chronicles
- FDA Imports and Exports / The Strategic and Operational Imperatives (Redi Spring 2015): Slides
- Compliance Considerations for Importing a Drug into the United States (REdI Fall 2014): Slides
- Compliance Considerations for Exporting a Drug to the Global Markets (REdI Fall 2014): Slides
- FDA’s Quality Metrics Reporting Program and the voluntary submission of Quality Metrics Data (11/30/2016)
- FDA’s Quality Metrics Reporting Program and the voluntary submission of Quality Metrics Data (11/30/2016): CDER SBIA Chronicles Podcast [MP3]
- BA/BE Inspections and Surveillance (REdl Fall 2016): Slides/Recording
- Ensuring Quality over the Product Lifecycle: Risk-based Product Specific Inspections in OPQ (REdl Fall 2016): Slides/Recording
- Revised Draft Guidance for Industry: Submission of Quality Metrics Data Webinar
- Pharmaceutical Quality Symposium: REdI Conference (July 2016): Slides
- Application of cGMPs to Drug Product Quality Microbiology Laboratory Tests and Manufacturing Process Validation (REdI Spring 2016): Slides/Recording
- Inspection of NDA and BLA Applications (REdI Spring 2016): Slides
- Risk and Team-based Integrated Quality Assessment in the Office of Pharmaceutical Quality (REdI Spring 2016): Slides/Recording
- The PAI/GMP Inspection (REdI Spring 2016): Slides
- FDA’s Office of Pharmaceutical Quality (4/4/16): CDER SBIA Chronicles
- FDA’s Pre-Approval Inspection (PAI) Program and How to prepare (Fall 2015): Slides
- Focus on CGMPs and FDA Inspections: REdI Conference (Summer 2015): Slides
- Request for Quality Metrics (7/25/15): Webinar
- The PAI / GMP Drug Inspection (REdI Spring 2015): Slides
- CMC: Improving Quality Submissions through the Product Lifecycle (REdI Fall 2014): Slides
- FDA Drug Quality Regulation: Current Topics (REdI Fall 2014): Slides
- FDA Drug Quality Regulation: Current Topics (REdl Spring 2014): Slides
- Drug Inspection Overview (REdI Spring 2014): Slides
- Post approval Changes Related to Drug Product Quality, Manufacturing and Controls(5/12/14): Webinar
- New Drug Quality (9/17/12): CDER SBIA Chronicles
- Building Quality into Clinical Trials (5/14/12): Webinar [ARCHIVED]
Additional Topics
BioResearch Monitoring Program, Drug Master File, Compounding, Drug ShortagesBioresearch Monitoring Program (BIMO)
- CDER BIMO Compliance and Enforcement (Redi Spring 2015): Slides
- CDER BIMO Compliance and Enforcement (Redi Spring 2015): Slides
- Strategic Quality for Clinical Trials, from Design through Reporting (4/21/11): Slides
- Preparing for an Inspection (4/21/11): Slides
- IND Process Public Workshop (10/8/10): Slides
Drug Master File (DMF)
Submitting Master Files in eCTD Format: When and How to Comply (5/25/2017): CDER SBIA Chronicles and Audio Podcast
- Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017 (8/4/16): Webinar
- New Requirement for Electronic Submission of Drug Master Files (2/4/16): Webinar
- DMF 101 (3/19/15): CDER SBIA Chronicles
- Introduction to the Drug Master File (11/14/11): Webinar [ARCHIVED]
Compounding
- The Complexities of Compounding - CDER SBIA Chronicles and Audio Podcast
- Fees Associated with Human Drug Compounding By Registered Outsourcing Facilities (4/24/15): Webinar
Drug Shortages
Can’t find what you are looking for?
Contact the CDER SBIA staff.
(866) 405-5367
(301) 796-6707
CDERSBIA@fda.hhs.gov
CDER SBIA
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993