12/18/2014
Federal Register Notice: FDA is making available a guidance: Providing Regulatory Submissions in Electronic Format — Submiss...12/16/2014
Federal Register Notice: FDA is correcting a 12/8 Federal Register notice that misstated the effective date of the new system of r...12/16/2014
Federal Register Notice: FDA’s proposed collection of information “Requirements for Submission of In Vivo Bioequivalen...12/16/2014
Federal Register Notice: FDA’s proposed collection of information “Records and Reports Concerning Experiences With App...12/05/2014
Federal Register Notice: FDA is making available a draft guidance for industry entitled How to Obtain a Letter from FDA Stating th...12/05/2014
Federal Register Notice: FDA is withdrawing approval of 23 NDAs and 68 ANDAs from multiple applicants. The holders of the applicat...12/04/2014
Federal Register Notice: FDA is making available a draft guidance for industry entitled Pregnancy, Lactation, and Reproductive Pot...12/04/2014
Federal Register Final rule: FDA is amending its regulations on the content and format of the “Pregnancy,” “Labo...