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  1. CDER Small Business & Industry Assistance (SBIA)

CDER SBIA YouTube Learning Library

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 20222021, 2020 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 2022 Presentations

  1. FDA Clinical Investigator Training Course (CITC) 2022

  2. FDA NanoDay Symposium 2022
  3. DMF Workshop: GDUFA III Enhancements and Structured Data Submissions – Session 3
  4. More 2022 Recordings...

Most Viewed 2021 Presentations

  1. Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it.

  2. CMC Considerations for Biotechnology Product Development: A Regulatory Perspective
  3. Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective
  4. More 2021 recordings...

Most Viewed 2020 Presentations

  1. Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs

  2. Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020
  3. Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method
  4. More 2020 recordings...

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