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Re: mrplmer post# 448057

Tuesday, 01/16/2024 4:30:15 PM

Tuesday, January 16, 2024 4:30:15 PM

Post# of 461947

The NDA
The NDA (38) includes all data concerning the drug; all information about the manufacturing process and facilities, quality control, and assurance; a complete product description (chemical formula, specifications, pharmacodynamics, and pharmacokinetics); indications; labeling; and proposed risk evaluation and mitigation processes if applicable. A typical NDA can run 100,000 pages, and according to the Office of the Federal Register, the application fee in 2016 for an NDA that requires clinical data is $2,374,200 39, 40. The FDA has 60 days to determine if they will file the application once it is received (41).



https://www.sciencedirect.com/science/article/pii/S2452302X1600036X

"The time has come," the Walrus said, "To talk of many things:..."

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