Federal Register notice: FDA submits to OMB an information collection extension for Animal Drug Adverse Event Reporting.
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 approves an Amag Pharmaceuticals supplemental NDA to broaden the existing label for Feraheme (ferumoxytol injection) beyond the current chronic ki...