Federal Register notice: FDA withdraws approval of 16 NDAs from multiple applicants.
Federal Register notice: FDA announces a 7/12 public meeting entitled Limited Population Pathway for Antibacterial and Antifungal Drugs.
FDA warns Indias B. Jain Pharmaceuticals about CGMP violations in its manufacturing of finished drug products.
FDA issues two more Warning Letters to Web sites selling illegal opioids online.
FDA announces a 5/31 public hearing for it to receive input on the agencys regulatory strategy and pathways for products containing cannabis or cannab...
FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram describe agency implementation of risk-based regulation of intentional genomic alte...
FDA warns Chinas Dong Yuan Technology Co. about CGMP violations in its production of finished pharmaceuticals.
A New York federal judge grants the government partial summary judgment in a whistleblower case alleging that Novartis participated in a company-wide ...