FDA warns Biotek India about CGMP violations in its manufacturing of OTC drugs and its marketing of a misbranded unapproved new OTC drug product.
FDA warns Smart Womens Choice that its vaginal contraceptive cream is an unapproved new drug.
Federal Register notice: FDA determines that Abraxis Pharmaceuticals injectable manganese sulfate 0.1 mg/mL was not withdrawn due to safety or effecti...
Federal Register notice: FDA makes available a final guidance entitled Bispecific Antibody Development Programs.
Federal Register notice: FDA sends to OMB an information collection revision on Shortages Data Collections.
FDA reports on South Koreas actions to combat Covid-19, particularly involving diagnostic tests.
Federal Register notice: FDA makes available a final guidance on molecularly targeted oncology drug pediatric studies.
FDA says Provention Bios teplizumab was successful in a submitted BLA trial in delaying the onset of Type 1 diabetes in at-risk patients.