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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Guidance on Lupus Nephritis Withdrawn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...