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CBERs Office of Compliance and Biologics Quality says that promotional materials for Omnix Evicel make inappropriate efficacy, sup...[ Price : $8.95]
PhRMA, Pfizer, and Merck suggest changes for FDA consideration for an ICH draft guidance on development and manufacture of drug su...[ Price : $8.95]
FDA says a Medicines Company shortage involving Cleviprex 0.5mg/ml 50 ml vials is now resolved.[ Price : $8.95]
Federal Register Notice: Advance notice of proposed rulemaking: FDA requests comments or information on non-face-to-face sale and ...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on the requirements for filing a notice of participation with FDA.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on the submission of warning plans for cigarettes and smokeless tobacco pro...[ Price : $8.95]
FDA clears a Fluke Biomedical 510(k) for the ProSim Vital Signs Simulator.[ Price : $8.95]
FDA approves a Mylan Pharmaceuticals ANDA for generic allergy drug promethazine hydrochloride tablets.