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Doctors for America calls on FDA to finalize a guidance on collecting race and ethnicity data in clinical trials and clinical stud...[ Price : $8.95]
FDA warns Banten, Indonesia-based P.T. Sankei Medical Industries about Quality System and Medical Device Reporting violations in t...[ Price : $8.95]
FDA approves an Aquestive Therapeutics ANDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereoty...[ Price : $8.95]
FDA clears a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac joint fusion cons...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Enforcement Policy for Certain In Vitro Diagnostic Devices ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Se...[ Price : $8.95]
AdvaMed calls for updates to FDA and HHS informed consent guidances.[ Price : $8.95]
FDA approves Boehringer Ingelheims high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable b...