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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...

Public Meeting on Generic Drug User Fee Act

12/08/2011

Federal Register Notice: FDA will hold a public meeting 12/19 to discuss proposed recommendations for enacting a Generic Drug User...

Info on MedWatch Sent to OMB

12/07/2011

Federal Register Notice FDA is announcing that a proposed collection of information, “MedWatch: The FDA Medical Products Rep...

Meeting to Discuss Biosimilar Biologic User Fees

12/07/2011

Federal Register Notice: FDA will hold a public meeting 12/16 to discuss the proposed recommendations for a user fee program for b...

FDA Cancels Dispute Panel Meeting on Ethicon Sedasys PMA

12/05/2011

Federal Register Notice: The 12/14 meeting of the Medical Devices Dispute Resolution Panel is canceled. The meeting was slated to ...

5 Drug Products Not Withdrawn for S&E

12/05/2011

Guidance on Blood Donor Testing to Reduce Hepatitis B

11/29/2011