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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5 Drug Products Not Withdrawn for S&E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

Guidance on Blood Donor Testing to Reduce Hepatitis B

11/28/2011

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Poole...

FDA Amends Emergency Authorization for Postal Service

11/28/2011

Federal Register Notice: FDA is amending the Emergency Use Authorization (EUA) for doxycycline hyclate tablet emergency kits for e...

Nominations Sought for Science Board

11/28/2011

Federal Register Notice: FDA requests nominations for voting members to serve on the Science Board to the FDA. Nominations receive...

FDA Withdraws NDA for Mylotarg

11/28/2011

Federal Register Notice: FDA is withdrawing approval of a Wyeth Pharmaceuticals’ NDA for Mylotarg (gemtuzumab ozogamicin) fo...

Science Board to Meet

11/28/2011

Federal Register Notice: FDA’s Science Board will meet 1/6/12 from 9 a.m. to 4 p.m. at the FDA White Oak Campus, 10903 New H...