This course will offer insight into the regulatory background of the NDA, outline how to prepare an NDA in CTD format, and review post-approval activities. The course will focus on drug and well-characterized biological products and not the regulatory process for devices, generic products or traditional biologics.
COURSE HIGHLIGHTS
•Overview, and roles and responsibilities of FDA
•NDA in CTD format
•Regulatory compliance and FDA inspections
•Post approval regulatory requirements for NDAs
•Regulatory requirements for prescription drug labeling
•Review of prescription drug/biologics advertising and promotional labeling.
COURSE HIGHLIGHTS
•Overview, and roles and responsibilities of FDA
•NDA in CTD format
•Regulatory compliance and FDA inspections
•Post approval regulatory requirements for NDAs
•Regulatory requirements for prescription drug labeling
•Review of prescription drug/biologics advertising and promotional labeling.
