Makary lauds user fees as FDA begins GDUFA IV reauthorization process The US Food and Drug Administration (FDA) on Friday began the reauthorization process for the next iteration of the Generic Drug ...
The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone ...
In a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which ...
UNITED STATES - JANUARY 22: Man Controlling Trade statue, FTC Building, Washington, D.C. (Photo by Carol M. Highsmith/Buyenlarge/Getty Images) The House passed bipartisan legislation last week that ...
Q&A on GDUFA implementation with Aloka Srinivasan, PhD, a principal consultant with Parexel and former team leader in FDA's Office of Generic Drugs. On July 9, 2012, the Generic Drug User Fee Act ...
On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team ...
The author discusses the key provisions of GDUFA as they relate to the pharmaceutical supply chain, including parity of inspections between domestic and foreign sites for both finished dosage forms ...
In a congressional cycle paralyzed by partisan gridlock, early reauthorization of PDUFA--the Prescription Drug User Fee Act--was hailed as a triumph for the current Congress. Not only did the law pass ...
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