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Federal Register Notice: FDA releases a guidance on considerations for plasmid DNA vaccines for infectious diseases.[ Price : $8.95]
GAO says FDA does not make clear to medical reviewers that they should assess NDA trial data for representation of elderly people ...[ Price : $8.95]
Sen. Chuck Grassley asks FDA commissioner Andrew von Eschenbach about reports the agency Drug Safety Oversight Board voted 8-7 to ...[ Price : $8.95]
FDA issues a draft guidance on collecting and disseminating financial interest information from advisory committee members.[ Price : $8.95]
FDA publishes a draft guidance for industry on developing drugs to treat acute bacterial sinusitis.[ Price : $8.95]
FDA approves a Novartis NDA for Tasigna (nilotinib), indicated for treating patients with Philadelphia chromosome-positive chronic...[ Price : $8.95]
FDA clears an ATS Medical 510(k) for the ATS Simulus Semi-Rigid Annuloplasty Ring for use in mitral valve repair procedures.[ Price : $8.95]
FDA issues a guidance for industry and agency staff answering questions about regulation of impact-resistant lenses for eyeglasses...