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FDA says it is considering implementing a master file pilot program for PMA holders whose approved devices are sterilized using ra...[ Price : $8.95]
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 eff...[ Price : $8.95]
FDA approves a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for treating adults with obesity or who ar...[ Price : $8.95]
FDA releases the FDA-483 with seven observations from an inspection at West Columbia, SC-based Nephron Sterile Compounding Center.[ Price : $8.95]
The CDER Office of Prescription Drug Promotion cautions Althera that a professional promotion for its cholesterol-lower drug Rosze...[ Price : $8.95]
Four senators sponsor bipartisan legislation to speed some interchangeable biologics to market.[ Price : $8.95]
A former employee at Eli Lilly files a wrongful termination suit against the pharmaceutical manufacturer, claiming she was fired i...[ Price : $8.95]
CDER Office of Drug Security, Integrity, and Response director Leigh Verbois tells how the APEC toolkit will be updated to address...