03/09/2015
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommend...03/09/2015
Federal Register Notice: FDA will co-sponsor with the American Association for Cancer Research and the American Society of Clinica...03/09/2015
Federal Register Proposed rule: FDA is extending the comment period until 5/18 for the proposed rule that appeared in the 12/18/14...03/03/2015
Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practices and Related R...03/03/2015
Federal Register Notice: FDA’s proposed collection of information, “Investigational New Drug (IND) Regulations —...03/03/2015
Federal Register Notice: FDA and NIH will co-sponsor a public scientific workshop 3/20 to discuss dystrophin protein quantificatio...03/03/2015
Federal Register Notice: CDER’s Division of Gastroenterology and Inborn Errors Products Division and Division of Pediatric a...02/17/2015
Federal Register Notice: CBER is inviting participants for its Regulatory Site Visit Training Program. It is intended to give CBER...