FDA acting commissioner Janet Woodcock calls for greater independence from drug companies in the nations clinical trial processes and procedures.
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Federal Register notice: FDA determines that Abraxis Pharmaceuticals injectable manganese sulfate 0.1 mg/mL was not withdrawn due to safety or effecti...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.