Learning Library Now Available on FDA’s YouTube Channel

FDA’s CDER Small Business and Industry Assistance (SBIA) is making hundreds of recordings available via a YouTube learning library.

Bookmark and share 2020, 2019, 2018, and 2017 recordings of webinar and conference presentations. New content will be posted on SBIA’s LinkedIn page.

Top Presentations for:

2020

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

2019

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

2018

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

2017

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

These subject matter expert presentations are intended to educate and help industry navigate FDA policies and procedures.

To earn free continuing education, register for upcoming CDER SBIA webinars and conferences.