FDA warns Becton Dickinson about Quality System issues at one of its manufacturing facilities.
FDA issues guidances to promote development of generic transdermal and topical delivery systems.
Qualigen has submitted a 510(k) for its FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay, indicated for the quantitative determination of S...
FDA medical reviewers tell members of the Anesthetic and Analgesic Drug Products Advisory Committee that they believe Trevenas oliceridine has a poten...
FDA denies a petition asking for a warning about the risk of esophageal cancer on labels for OTC heartburn products.
Federal Register notice: FDA makes available two new product-specific draft guidances for submitting ANDAs for capsaicin and estradiol (norethindrone ...
The CDER Office of New Drugs suggests a way that Agile Therapeutics can proceed with its Twirla contraceptive patch that received a 2017 complete resp...
FDA clears Eximo Medical 510(k) for the B-Laser Atherectomy System for treating peripheral artery disease.