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Body Fusion Device May Go into Class 2

02/09/2006

Federal Register Proposed rule: FDA is proposing to reclassify intervertebral body fusion devices that contain bone grafting mater...

Guidance on Pharmacogenetic/Genetic Tests

02/09/2006

Federal Register Notice: FDA is making available a draft guidance entitled Pharmacogenetic Tests and Genetic Tests for Heritable M...

FDA OKs Bayer Tablets for Canine Parasites

02/09/2006

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Bayer Healthcare LLC supplementa...

Hepatitis A Virus Assays Go into Class 2

02/09/2006

Federal Register Final rule: FDA is reclassifying hepatitis A virus (HAV) serological assays from Class 3 (premarket approval) int...

Review Period Set for Alimta

02/08/2006

Federal Register Notice: FDA has determined the regulatory review period for Eli Lilly and Co.’s Alimta is 4,166 days for the exte...

Emergency Anthrax Vaccine Use Expires

02/01/2006

Federal Register Notice: FDA is issuing notice of the termination by expiration of the emergency declaration justifying emergency ...

Pediatric Panel to Meet

02/01/2006

Federal Register Notice: FDA’s Pediatric Advisory Committee will meet 3/22, from 8 a.m. to 6 p.m. at Washington DC North/Gaithersb...

Panel to Discuss 2006-07 Influenza Vaccine

02/01/2006

Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 2/17, from 1 p.m. to 5:30 p.m...

Blood Establishments That Can Distribute Derivatives

02/01/2006

Federal Register Proposed rule: FDA proposes to amend its regulations to allow certain registered blood establishments that qualif...

Review Period Set for Humira

02/01/2006

Federal Register Notice: FDA has determined the regulatory review period for Abbott’s Humira is 1,722 days for the extension of a ...