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
鈥verview, and roles and responsibilities of FDA
鈥DA in CTD format
鈥egulatory compliance and FDA inspections
鈥ost approval regulatory requirements for NDAs
鈥egulatory requirements for prescription drug labeling
鈥eview of prescription drug/biologics advertising and promotional labeling.
COURSE HIGHLIGHTS
鈥verview, and roles and responsibilities of FDA
鈥DA in CTD format
鈥egulatory compliance and FDA inspections
鈥ost approval regulatory requirements for NDAs
鈥egulatory requirements for prescription drug labeling
鈥eview of prescription drug/biologics advertising and promotional labeling.
