FDA releases substantive Warning Letters in the last two weeks of December 2025.
In a PDUFA 8 reauthorization subgroup discussion, FDA and industry representatives trade data and evaluations of first-cycle reviews and debate whethe...
Two lengthy news service stories raise questions about FDAs approach to vaccines being espoused by CDER director Tracy Beth Heg and CBER director Vina...
FDA announces a 1/14 town hall to discuss its Quality Management System Regulation (QMSR) and its effective date of 2/2/2026.
FDA issues a complete response letter to Sanofis NDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis in adults.
An inspection of a Dr. Reddy's India manufacturing plant raises significant GMP issues in a new Form FDA 483.
Lawmakers introduce bipartisan legislation in the House and Senate to provide a skinny label safe harbor for certain human and animal drugs.
FDA warns Montague, MI-based Tower Laboratories about CGMP violations in its manufacture of finished drugs.
