FDA’s CDER Small Business and Industry Assistance (SBIA) is making available our YouTube learning library - now hundreds of our recordings are readily accessible.
Bookmark and share 2021, 2020, 2019, 2018, and 2017 recordings of webinar and conference presentations. New content will be posted on SBIA’s LinkedIn page, and top viewed presentations will be updated quarterly. The subject matter expert presentations are intended to educate and help industry navigate FDA policies and procedures.
Register for upcoming CDER SBIA webinars and conferences to learn directly from FDA subject matter experts and earn free continuing education.
Most Viewed 2021 Presentations
Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective
- Drug Master File (DMF) Submissions on New FDA Form 3938
- Risk Evaluation and Mitigation Strategies (REMS) Compliance Program
- More 2021 recordings...
Most Viewed 2020 Presentations
Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
- Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products
- Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method
- More 2020 recordings...
Most Viewed 2019 Presentations
NDA and BLA Application Review Process (6of15) REdI Annual Conference – May 29-30, 2019
- Electronic Common Technical Document (eCTD) and Study Data (7/15) REdI
- Components of New Drug Application and Biologics License Application (5of15) REdI– May 29-30, 2019
- More 2019 recordings...
Most Viewed 2018 Presentations
Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018
- Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6/14) REdI 2018
- Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018
- More 2018 recordings...
- CDER SBIA Learn—multimedia training resources, including conference/webinar presentations and recordings, online courses, newsletters and podcasts
- Search for Regulatory References