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Welcome to the Regulatory Affairs Explained Series! In episode 1 we discuss the Food and Drug Administration (FDA), Application Types, Regulatory Pathways & More!

Time Stamp⏰:
0:00 0:29 Introduction
0:30 1:00 Order The Prepared Graduate Today!
1:01 2:16 What is the FDA?
1:27 3:29 CDER vs CBER
3:30 3:57 What is an IND?
3:58 4:34 What is an NDA/BLA?
4:35 5:43 What is an sNDA/sBLA?
5:44 6:07 Over the Counter Application
6:08 7:31 What is the 505(b)(1) Regulatory pathway?
7:32 7:54 What is the 505(b)(2) Regulatory pathway?
7:55 9:15 What is the 505(j) pathway?
9:16 9:53 The importance of Regualtory Strategy
9:54 10:24 Conclusion

To learn more about INDs at the FDA visit this link: https://www.fda.gov/drugs/typesappli...

To learn more about NDAs at the FDA visit this link: https://www.fda.gov/drugs/typesappli...

To learn more about biologics (BLAs) at the FDA visit this link: https://www.fda.gov/vaccinesbloodbi...

There is a lot to learn about regulatory affairs, so make sure you subscribe and turn on post notifications so you don't miss episode 2!

Commonly used acronyms:
FDA Food and Drug Administration
IND Investigational New Drug Application
NDA New Drug Application
BLA Biologics License Application
sNDA Supplemental New Drug Application
sBLA Supplemental Biologics License Application
CDER Center for Drug Evaluation and Research
CBER Center for Biologics Evaluation and Research



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