FDA cites Lonza Portsmouth for significant manufacturing and quality control deficiencies at its cell therapy facility where Vertex Pharmaceuticals an...
A Washington Post opinion article takes issue with FDAs recent decision to reject a low-dose atropine treatment for pediatric myopia despite a large c...
FDA moves to blunt criticism of the Commissioners National Priority Voucher Program with a news release containing 18 questions and answers, making th...
FDA warns Mark Dacey of Denver, CO, about failing to obtain informed consent for two clinical investigations he conducted.
FDA and industry representatives report agreement on several issues in the 1/21 MDUFA 6 negotiating session.
FDA approves changes to the isotretinoin REMS to take effect in 180 days.
FDA issues a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation, citing widespread GMP violations at the companys Houston facility...
FDA accepts for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type 1.
