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Risk Panel to Discuss Info Available to Patients

12/08/2008

Federal Register Notice: FDA’s Risk Communication Advisory Committee will meet 2/26, from 8 a.m. to 5 p.m. and 2/27, from 8 ...

Guidance on Data Retention on Withdrawn Trial Participants

12/01/2008

Federal Register Notice: FDA is making available a guidance, Data Retention When Subjects Withdraw from FDA-Regulated Clinical Tri...

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Federal Register Notice: FDA is making available, Draft Guidance for Industry: Small Entities Compliance Guide for Renderers &mdas...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