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Endo disagrees with Office of Generic Drug recommendations for the kinds of studies needed to demonstrate bioequivalence to its Li...[ Price : $8.95]
The District of Columbia U.S. Attorney calls former commissioner Lester Crawfords financial disclosure and conflict of interest vi...[ Price : $8.95]
CDRH medical device quality systems expert Kimberly Trautman tells RAPS that complaints received by manufacturers may not be the b...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on fixed dose combinations, co-packaged drug products, and single-entity versions...[ Price : $8.95]
Federal Register Notice: FDA posts summaries of pediatric studies for Altace, Gemzar, Lescol, Sandostatin LAR, and Serevent.[ Price : $8.95]
The FDA Alliance hire Washington attorneys Stuart Pape and Ed Newberry (Patton Boggs) as its lobbyists to pursue high congressiona...[ Price : $8.95]
CBER finalizes a guidance with its thinking on reporting biological product deviations.[ Price : $8.95]
Albers Medical Distributors owner Douglas Albers enters a guilty plea for his role in selling counterfeit and misbranded Neupogen ...