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FDA accepts for review a Puma Biotechnology NDA for its lead product candidate PB272 (neratinib), indicated for the extended adjuv...[ Price : $8.95]
Federal Register Notice: FDAs Risk Communication Advisory Committee meets 11/ to discuss and make recommendations on the agencys d...[ Price : $8.95]
Federal Register Notice: FDA announces the 2016 FDA Naloxone App Competition, a prize competition designed to help reduce deaths a...[ Price : $8.95]
A summary of an internal CDER dispute surrounding the approval of Sareptas controversial Duchenne drug Exondys 51 shows that Cente...[ Price : $8.95]
FDA posts a draft guidance on FDAs Application of Statutory Factors in Determining When a REMS Is Necessary.[ Price : $8.95]
FDA solicits comment on a draft guidance to assist drug sponsors and medical device manufacturers who want to coordinate developme...[ Price : $8.95]
FDA issues a guidance on reporting formats for medical device computational modeling and simulation studies.[ Price : $8.95]
Alcon calls on FDA to eliminate the in vitro option for bioequivalence testing for generic Durezol.