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FDA gives advisors surgical mesh adverse event reports to consider during a 9/8-9 meeting.[ Price : $8.95]
A new FDA drug safety alert warns about serious allergic reactions that have been reported with Merck's antipsychotic Saphris (ase...[ Price : $8.95]
FDA says it will review a Vivus avanafil NDA with a proposed indication for treating erectile dysfunction.[ Price : $8.95]
FDA releases a draft performance agreement for the PDUFA 5 reauthorization.[ Price : $8.95]
Consumer advocates tell FDA advisors that the inability of breast implant manufacturers to track patients in post-approval studies...[ Price : $8.95]
Federal Register Advanced notice of proposed rulemaking: The comment period is extended until 10/26 on how to modernize current re...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on the format for NDA and ANDAs for positron emission tomography drugs.[ Price : $8.95]
PhRMA defends industry patent settlements in the wake of an 8/31 FTC report on authorized generics.