ORDER MY DEBUT BOOK, THE PREPARED GRADUATED, TODAY! Visit https://www.amazon.com/Prepared-Gradu...

The Prepared Graduate is the best book offering professional advice. It provides:
👨🏽‍💻 Guidance on finding the right path for career success
🛣 An easy-to-follow roadmap with advice about career preparation
💼 Endless job search tips & more

💙 Get private career coaching from Kyyah here: https://www.careersavage.com/services...

💙 Career Savage Job Search Strategy: https://www.careersavage.com/services...

💙 Get Your Resume Done: https://www.careersavage.com/services...

---------
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/types-appli...

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

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

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

---

🚨FOLLOW ME🚨
Career Savage:
Website: http://www.careersavage.com
Instagram:   / careersavage  
Tiktok:   / careersavage  
Twitter:  / careersavage  

Kyyah Abdul:
Website: www.kyyahabdul.com
Instagram:   / kyyahabdul  
Twitter:   / kyyahabdul  
Tiktok:   / kyyahabdul  
Pinterest:   / kyyahabdul  

#regulatoryaffairs #RegualtoryExplained #FDA