News: F.D.A.’s Drug Industry Fees Fuel... (The New York Times) - Behind the headlines
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F.D.A.’s Drug Industry Fees Fuel Concerns Over Influence
The pharmaceutical industry finances about 75 percent of the agency’s drug division, through a controversial program that Congress must reauthorize by the end of this month.
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The Prescription Drug User Fee Act: Much More Than User Fees
The need for PDUFA reauthorization every 5 years has created a recurring legislative vehicle through which far-ranging changes to FDA have been enacted, reshaping the age …
US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018
Although the program expedited the approval of nononcology drug indications by a median (IQR) of 53.1 (26.8-133.2) months, safety-related label modifications were often a …
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