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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 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

  1. Drug Master File (DMF) Submissions on New FDA Form 3938

  2. Timeline for the Drug Master Review Process
  3. Risk Evaluation and Mitigation Strategies (REMS) Compliance Program
  4. More 2021 recordings...

Most Viewed 2020 Presentations

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

  2. Establishment Registration and Drug Listing Compliance Program – DRLS Workshop 2020
  3. Promoting Safe and Effective Prescription Drug Use in Geriatric Patients
  4. More 2020 recordings...

Most Viewed 2019 Presentations

  1. NDA and BLA Application Review Process (6of15) REdI Annual Conference – May 29-30, 2019

  2. Components of New Drug Application and Biologics License Application (5of15) REdI– May 29-30, 2019
  3. Electronic Common Technical Document (eCTD) and Study Data (7of15) RedI – May 29-30, 2019
  4. More 2019 recordings...

Most Viewed 2018 Presentations

  1. Chemistry, Manufacturing, and Controls (CMC) for an IND (7of14) REdI 2018

  2. Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018
  3. Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3of14)
  4. More 2018 recordings...

Most Viewed 2017 Presentations

  1. Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017

  2. Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017
  3. Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017
  4. More 2017 recordings...

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