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A King & Spalding legal analysis examines FDAs newly announced pilot program for one-day inspectional assessments, suggesting it m...[ Price : $8.95]
FDA warns Israels Naveh Pharma and Atlanta, GA-based Bigdam about selling unapproved new drugs that are adulterated by CGMP violat...[ Price : $8.95]
FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was prep...[ Price : $8.95]
Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.[ Price : $8.95]
An FDA Federal Register notice requests information from drug developers and academic investigators to support a pilot project foc...[ Price : $8.95]
Ipsen withdraws its cancer drug Tazverik (tazemetostat) from the U.S. market after new clinical trial data showed an increased ris...[ Price : $8.95]
A March inspection of SCA Pharmaceuticals cites multiple manufacturing and contamination-control deficiencies at its outsourcing f...[ Price : $8.95]
FDA warns Indias Ashirwad Hospital Center and clinical investigator Mukesh Chandre about failing to obtain informed consent for a ...