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#2
4th March 2016, 01:44 PM
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| Re: Nda pdufa
Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes by FDA (Food and Drug Administration ) Not by NDA. It is act related to collection of fees from companies that produce certain human drug and biological products. Prescription Drug User Fee Rates: Application w/Clinical $2,374,200 Application w/o Clinical $1,187,100 Supplement w/Clinical $1,187,100 Product $114,450 Establishment $585,200 PDUFA include information about the : Application Fees Establishment Fees Product Fees Waivers, Reductions, and Refunds FDA :PDUFA Detail  Contact Detail : Prescription Drug User Fee Staff Food and Drug Administration 10001 New Hampshire Avenue, Room 3179 Silver Spring, MD 20993-0002 U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) |