FDA says it is considering implementing a master file pilot program for PMA holders whose approved devices are sterilized using radiation.
Federal Register notice: FDA posts a list of PMAs that have been approved from 1/1/2021 through 2/14/2022 that have safety and effectiveness summaries...
FDA approves a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for treating adults with obesity or who are overweight with at...
FDA releases the FDA-483 with seven observations from an inspection at West Columbia, SC-based Nephron Sterile Compounding Center.
The CDER Office of Prescription Drug Promotion cautions Althera that a professional promotion for its cholesterol-lower drug Roszet contains false and...
Four senators sponsor bipartisan legislation to speed some interchangeable biologics to market.
A former employee at Eli Lilly files a wrongful termination suit against the pharmaceutical manufacturer, claiming she was fired in retaliation for ra...
CDER Office of Drug Security, Integrity, and Response director Leigh Verbois tells how the APEC toolkit will be updated to address changing conditions...