Federal Register notice: FDA makes available a draft guidance entitled Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Tria...
Federal Register notice: FDA makes available a final guidance entitled Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT...
FDA releases a guidance, S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmonization; Guidance for...
FDA revises the authorized uses and is requiring updates to product labeling regarding repeat (serial) testing for all currently authorized Covid-19 a...
Two stakeholders comment on an FDA workshop on advancing premarket safety analytics.
Bristol Myers Squibb reports that its COMMANDS Phase 3 study evaluating Reblozyl (luspatercept-aamt) met its primary endpoint in first-line treatment ...
FDA recommends that health care providers discuss alternative magnetic resonance imaging-guided breast biopsy options with patients if facilities are ...
FDA alerts patients and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical....
