02/03/2016
Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Human Factors Studies and Re...01/28/2016
Federal Register Notice: FDA seeks public comments on the procedure by which an applicant may obtain an assignment or designation ...01/28/2016
Federal Register Notice: FDA is making available a revised draft guidance for industry on lamotrigine extended-release tablets ent...01/28/2016
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommend...01/28/2016
Federal Register Notice: FDA’s Cincinnati District and Xavier University will co-sponsor a public conference 5/4-6 entitled ...12/14/2015
Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 2/18/16,...12/10/2015
Federal Register Notice: FDA has determined the regulatory review period for Janssen Pharmaceutica’s Sirturo is 2,213 days f...12/10/2015
Federal Register Notice: FDA has determined the regulatory review period for Bristol-Myers Squibb’s Eliquis is 3,685 days fo...