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

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Welcome to the Regulatory Affairs Explained Series! In Episode 3 we discuss Common documents, Forms, ClincialTrials.gov & More!

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-applications/new-drug-application-nda

To learn more about biologics (BLAs) at the FDA visit this link: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber

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 4!

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
https://youtu.be/cMpCziE9m-0

Regulatory Affairs Explained Episode 2: Requesting Meetings, Meeting Types, Timelines & More https://youtu.be/4unzgiwEY1c

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#RegulatoryAffairs #Regulatory #RegulatoryExplained

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