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President Trump says he has asked FDA to cut through red tape and reduce regulatory barriers, presumably to advance products assoc...[ Price : $8.95]
CDER denies an Acer Therapeutics appeal of a 6/2019 complete response letter on an NDA for Edsivo (celiprolol) for treating vascul...[ Price : $8.95]
Janssen Pharmaceutical files an NDA for ponesimod for treating adult patients with relapsing multiple sclerosis.[ Price : $8.95]
FDA warns Indias Cipla Limited about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA warns Gojo Industries its Purell Healthcare Advanced Hand Sanitizer product line is considered an unapproved new drug that can...[ Price : $8.95]
FDA publishes a draft guidance on using flow restrictors for oral liquid drug products to limit unintentional ingestion by childre...[ Price : $8.95]
FDA warns Indias Windlas Healthcare Private Limited about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA postpones a 4/16 advisory committee meeting that was to review a TransMedics PMA for the TransMedics Organ Care System.