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Time Changed on Pediatric Ethics Subcommittee Meeting

12/01/2008

Federal Register Notice: FDA is amending an 11/14 notice of a meeting of its Pediatric Ethics Subcommittee of the Pediatric Adviso...

FDA OKs Elanco Animal NADA for turkey feed

12/01/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Elanco Animal Health NADA that ...

FDA Revokes Cephalosporin Prohibition

11/26/2008

Federal Register Final rule: FDA is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food...

Guidance on Substances Prohibited in Animal Feed

11/26/2008

Federal Register Notice: FDA is making available, Draft Guidance for Industry: Small Entities Compliance Guide for Renderers &mdas...

Info on Med Guide Requirements Sent to OMB

11/26/2008

Federal Register Notice: FDA’s proposed collection of information, Prescription Drug Product Labeling: Medication Guide Requ...

Comments Sought on TV Drug Ad Toll-Free Numbers

11/26/2008

Federal Register Notice: FDA is seeking comments on a study examining the impact on consumer comprehension of inclusion of a toll-...

Workshop on Sex Differences in Cardio Device Trials

11/26/2008

Federal Register Notice: FDA and AdvaMed are co-sponsoring a public workshop 12/9, “Sex Differences in the Cardiovascular De...

Panel to Discuss Erbitux and Vectibix Oncology Drugs

11/21/2008

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 12/16, from 8 a.m. to 4 p.m. at the Hilton Washi...

Nubain Not Withdrawn for S&E

11/21/2008

Federal Register Notice: FDA has determined that Nubain (nalbuphine hydrochloride) injection, 10 and 20 mg/ml, was not withdrawn f...

Comments Sought on Single-Use Device Labeling

11/17/2008

Federal Register Notice: FDA seeks comments on reprocessed single-use device labeling, “Compliance With Section 301 of the M...