FDA releases a form FDA-483 with six observations from an inspection at India’s Global Calcium active pharmaceutical ingredient manufacturing facility.
Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, especially for vulnerable populations.
FDA releases a form FDA-483 with six observations from an inspection at India’s Global Calcium active pharmaceutical ingredient manufacturing facility.
Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, especially for vulnerable populations.
FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss.
FDA commissioner Marty Makary says the agency is not planning to eliminate direct-to-consumer pharmaceutical advertising, even as it ramps up enforcement against misleading promotions.
