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 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.
FDA warns Tampa, FL-based LiquidCapsule Manufacturing about repeated CGMP violations in its production of finished drugs.
FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.
FDA posts a guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, D...
