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Welcome to the Regulatory Affairs Explained Series! In Episode 4 we discuss Electronic Common Technical Document (eCTD) Modules

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 5!

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
IB Investigators Brochure
IMPD Investigational Medicinal Product Dossier
WRO Written Responses Only
BP or BB Briefing Package or Briefing Book
MR Meeting Request
EOP End of Phase
INTERACT Initial Targeted Engagement for Regulatory Advice on CBER producTs

Check out the other episodes in this series!

Regulatory Affairs Explained Episode 1: FDA, Application Types, Regulatory Pathways & More
   • Regulatory Affairs Explained Episode ...  

Regulatory Affairs Explained Episode 2: Requesting Meetings, Meeting Types, Timelines & More    • Regulatory Affairs Explained Series E...  

Regulatory Affairs Explained Series Episode 3 | Common Documents, Forms, ClinicalTrials.gov & More    • Regulatory Affairs Explained Series E...  



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