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FDA issues a guidance explaining when the agency will not take action regarding requiring stability studies for repackaged product...[ Price : $8.95]
FDA issues a draft guidance to help applicants comply with content and format requirements for drug label subsections on pregnancy...[ Price : $8.95]
FDA issues a guidance on using pathological complete response as an endpoint for accelerated approval of drugs to treat high-risk ...[ Price : $8.95]
The Justice Department says Pacira Pharmaceuticals is paying $3.5 million to resolve a whistleblower charge that it provided kickb...[ Price : $8.95]
FDA clears a Neocis 510(k) for a new Yomi edentulous indication for its robot-assisted dental surgery system.[ Price : $8.95]
FDA updates its inactive ingredient database to allow users to perform electronic queries to obtain accurate maximum daily exposur...[ Price : $8.95]
FDA tells the GAO that a provision in the CARES Act should help it address more quickly safety issues in OTC drugs.[ Price : $8.95]
FDA posts a new template for commercial developers to help them develop and submit emergency use authorization requests for Covid-...