FDA clears an Orthofix International 510(k) for its new internal fixation system, the G-Beam Fusion Beaming System, intended for use in treating Charc...
FDA says there have been 414 medical device adverse event reports on breast implant-associated anaplastic large cell lymphoma.
Attorney Mark Schwartz says the FDA quality metrics data reporting program appears to be on hold due to concerns about its burden on industry.
FDA approves a Sun Pharmaceutical Industries NDA for Ilumya (tildrakizumab-asmn) for treating adults with moderate-to-severe plaque psoriasis who are ...
Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Safety Reporting for Combination Products.
Federal Register notice: FDA makes available an immediately in effect guidance entitled Compliance Policy for Combination Product Postmarketing Safety...
FDA approves an expanded indication for Seattle Genetics Adcetris to treat adults with previously untreated stage 3 or 4 classical Hodgkin lymphoma in...
Three FDA executives say the agency is increasing staff and technology to intercept packages containing illegal products with hidden drug substances c...