FDA Withdraws Rule on Agreements, MOU
06/27/2012
Federal Register Direct final rule: Due to significant adverse comment, FDA is withdrawing a 3/23 direct final rule making technic...
FDA Sends Info on Device Decision Analysis to OMB
06/27/2012
Info on FDAAA OK’d by OMB
06/27/2012
OMB OKs Info on Filing Objections, Hearing Requests
06/21/2012
Panel to Discuss Abbott’s Humira for Colitis
06/21/2012
Federal Register Notice: FDA’s Gastrointestinal Drugs Advisory Committee will meet 8/28, from 8 a.m. to 5 p.m. at the Double...
Info on Notice of Participation OK’d by OMB
06/21/2012
Federal Register Notice: FDA’s collection of information, “Notice of Participation,” has been approved by the Of...
OMB OKs Info on Usability Testing
06/21/2012
Federal Register Notice: FDA’s collection of information entitled “Data to Support Communications Usability Testing, a...
Comments Sought on Device User Fee Form
06/06/2012
Federal Register Notice: FDA is seeking comments on a proposed collection of information by the agency, “Form FDA 3601 &mdas...
Surrogate Endpoints for Breast Cancer Drug Accelerated Approval
05/30/2012
Federal Register Notice: FDA is making available a draft guidance for industry entitled Pathologic Complete Response in Neoadjuvan...
Animal Drug Sponsor Changed to Elanco
05/30/2012
Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for 17 NADAs and ANADAs fo...
