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FDA clears a Loma Vista Medical 510(k) for its True Dilatation Balloon Valvuloplasty Catheter.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance, eCopy Program for Medical Device Submissions.[ Price : $8.95]
Federal Register Notice: FDA cancels an 11/8 meeting of the Oncologic Drugs Advisory Committee scheduled to discuss a Celgene NDA ...[ Price : $8.95]
House Energy and Commerce Committee members say they want a complete history of FDAs oversight on New England Compounding Center t...[ Price : $8.95]
Ben Venue Laboratories resumes production on a limited number of manufacturing lines at its troubled Bedford, OH facilities.[ Price : $8.95]
FDA medical reviewers tell the Endocrinologic and Metabolic Drugs Advisory Committee that they have safety concerns about Genzymes...[ Price : $8.95]
Attorneys Kurt Karst and Jeffrey Gibbs say it is unfortunate that a federal appeals court wont get to rule on the litigation betwe...[ Price : $8.95]
Former FDA deputy commissioner Scott Gottlieb says some recent politically-directed policy changes in FDA drug regulation may make...