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5 Drug Products Not Withdrawn for S&E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...
OMB OKs Info on Biologic AERs
11/28/2011
FDA OKs Merial NADA for Bovine Parasites
11/28/2011
Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an original NADA filed by Merial L...
