Consumer-health advocacy group Citizens for Health urges FDA commissioner Scott Gottlieb to remove a Pew Charitable Trusts representative from the age...
FDA issues a safety alert warning healthcare providers of venous thromboembolism, including pulmonary embolism, in patients who received autologous im...
FDA reminds all ANDA and NDA holders about a one-time report that is due 2/14 on the market status for all approved drug products.
United Health Products files a PMA for HemoStyp for use in internal procedures.
CDER and CBER release their Data Standards Strategy FY2018-FY2022 that commits the centers to continue the development, implementation, and maintenanc...
FDA posts a Form 483 from a 1/24-completed inspection of Houston, TX-based Empower Pharmacy that cites a repeat observation from an earlier inspection...
Federal Register notice: FDA classifies the percutaneous nerve stimulator for substance use disorders into Class 2 (special controls).