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Steady_T

09/14/23 8:29 PM

#430629 RE: abew4me #430611

Abe. We have had this discussion before. There is nothing in the FDA rules about repurposing a drug expediting the approval process.
You found an article that discussed that but there is nothing in the FDA rules that supports that article.
Yes there are parts of an NDA that can be recycled. The Mfg facility inspections etc.

Have you found something more in the FDA rules since we last discussed this?