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thefamilyman

12/09/14 5:46 PM

#81394 RE: TheDane #81385

QIDP makes B eligible for Fast Track AND Priority Review. The document you linked has excellent info about both of these programs.

On page 8...

Title VIII of FDASIA, Generating Antibiotic Incentives Now (GAIN), provides incentives for the development of antibacterial and antifungal drugs for human use intended to treat serious and life threatening infections. Under GAIN, a drug may be designated as a qualified infectious disease product (QIDP) if it meets the criteria outlined in the statute. A drug that receives QIDP designation is eligible under the statute for fast track designation and priority review.



It goes on to say...

However, QIDP designation is beyond the scope of this guidance.



The document you found does not specifically address the details of GAIN and QIDP beyond that statement.