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In its latest batch of Warning Letters, FDA cites Gentell and St. Jude Medical.[ Price : $8.95]
FDA posts a draft guidance on Manufacturing Site Change Supplements: Content and Submission that explains the agencys current thin...[ Price : $8.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on device reclassification petit...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an information collection on administrative detention and banned medical devices.[ Price : $8.95]
Federal Register Notice: FDA plans a meeting 11/30: Office of Womens Health General Update on Strategic Priorities and Initiatives...[ Price : $8.95]
The new Patients Alliance for Drug Safety Protections opens an online resource on the benefits of REMS.[ Price : $8.95]
Otsuka asks a federal court to reverse FDAs decision to approve an Alkermes NDA for Aristada.[ Price : $8.95]
FDA tells Neos Therapeutics that it has identified deficiencies that preclude discussion of labeling and postmarketing requirement...