OMB Approves State Enforcement Notifications Info
06/27/2012
Federal Register Notice: FDA’s collection of information entitled “State Enforcement Notifications” has been app...
Info on Postmarket ADERs Sent to OMB
06/27/2012
Federal Register Notice: FDA’s proposed collection of information, “Postmarketing Adverse Drug Experience Reporting &m...
Guidance on Lupus Nephritis Withdrawn
06/27/2012
Federal Register Notice: FDA is withdrawing a 6/22/10 guidance, Lupus Nephritis Caused By Systemic Lupus Erythematosus — Dev...
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...