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  1. Development & Approval Process | Drugs

CDER SBIA 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 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 2020 Presentations

  1. Conducting Clinical Trials During the COVID-19 Public Health Emergency

  2. Current Global Generic Drug Landscape
  3. Facility Readiness: GMPs, Quality Assessments, and Compliance Trends
  4. More 2020 recordings...

Most Viewed 2019 Presentations

  1. Most Common Issues with CDISC-SEND Data in FDA Toxicology Review

  2. Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)
  3. FDA Study Data Technical Conformance Guide v4.4
  4. More 2019 recordings...

Most Viewed 2018 Presentations

  1. Pre-ANDA review: Office of Pharmaceutical Quality (OPQ)

  2. Questions and Panel Discussion - Complex Generics 2018
  3. Good ANDA Submission and Assessment Practices and Software Support
  4. More 2018 recordings...

Most Viewed 2017 Presentations

  1. Optimizing Your Study Data Submissions to FDA: Study Data Technical Conformance Guide

  2. Case Study: Micro Investigation of Contamination by Burkholderia multivorans
  3. REMS Integration Initiative: an Overview
  4. More 2017 recordings...

 

 

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