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An FDA guidance says the agencys preferred unique facility identifier for domestic and foreign drug establishments is the Data Uni...[ Price : $8.95]
FDA denies a Hope Pharmaceuticals petition asking that companies filing NDAs or ANDAs for sodium nitrate or sodium thiosulfate dru...[ Price : $8.95]
Deming, NM oncologist Mohamed Basel Aswad enters a guilty plea on charges he caused the unlawful introduction of misbranded drugs ...[ Price : $8.95]
FDA approves Ranbaxy Laboratories fenofibrate capsules USP, 43 mg and 130 mg, a generic of Lupins Antara for treating high cholest...[ Price : $8.95]
FDA posts a draft guidance on Bioequivalence Recommendations for Concerta (methylphenidate hydrochloride) extended-release tablets...[ Price : $8.95]
Novo Nordisk announces new data from its Phase 3a SCALE obesity and pre-diabetes trial that showed 92% of participants lost weight...[ Price : $8.95]
FDA notifies the DC federal district court that it will appeal a 9/5 court order granting Depomeds motion for summary judgment com...[ Price : $8.95]
An OFW Law client tells FDA it supports a petition asking the agency to rule that Ranbaxy has lost its 180-day exclusivity for sev...