Federal Register notice: FDA seeks comments on an information collection entitled Testing Communications by FDAs Center for Devices and Radiological H...
Federal Register notice: FDA makes available a draft guidance entitled Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Tria...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...
Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.
Federal Register notice: FDA seeks comments on an information collection extension entitled Biologics License Applications Procedures and Requirements...
FDA posts a draft guidance on recommendations for measuring and recording growth, and evaluating pubertal development for evaluating safety in pediatr...
