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Devices Panel to Discuss Medtronic PMA

02/08/2007

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 3/1, fro...

FDA OKs First Priority ANADA for Dogs

02/08/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a First Priority Inc. ANADA that p...

‘Accelerated Enforcement’ Now Against Unapproved Drugs

02/08/2007

During the coming year, FDA intends to accelerate enforcement of regulations pertaining to currently unapproved and unregulated dr...

Panel to Discuss Animals Exposed to Anesthetic Drugs

02/07/2007

Federal Register Notice: FDA’s Anesthetic and Life Support Drugs Advisory Committee will meet 3/29, from 8 a.m. to 5 p.m. at...

Vaccines Panel to Meet

02/07/2007

Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 2/27, from 8 a.m. to 5:...

Antiviral Drugs Panel to Discuss Pfizer NDA

02/07/2007

Federal Register Notice: FDA’s Antiviral Drugs Advisory Committee will meet 4/24, from 8 a.m. to 4 p.m. at CDER’s Advi...

Harmonization Study Groups Release Device Reports

02/06/2007

Federal Register Notice: FDA is announcing the availability of proposed and final documents that have been prepared by Study Group...

FDA OKs Eka Chemicals NADA for Finfish

02/06/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Eka Chemicals, Inc. NADA for im...

Approved PMAs List is Published

01/26/2007

Federal Register Notice: FDA is publishing a list of PMAs that have been approved and is making available the safety and effective...

Comments Sought on Human Cells, Tissues Regulations

01/26/2007

Federal Register Notice: FDA is seeking public comment on the information collection requirements for agency regulations related t...