FDA warns Indias Lupin Limited about CGMP deviations in the production of active pharmaceutical ingredients.
FDA researchers say industry use of the accelerated approval, breakthrough therapy, fast track, and priority review programs has increased since 2008 ...
FDA says it is deferring action on an Amicus BLA for cipaglucosidase alfa as part of a treatment for Pompe disease until the agency can conduct a manu...
Pfizer plans a year-end BLA for its investigational bivalent respiratory syncytial virus vaccine after stopping enrollment in a Phase 3 study that it ...
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Federal Register notice: FDA makes available a draft guidance entitled Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Tria...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...
