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FDA OKs Elanco Animal Health Drug for Dog Fleas

10/25/2007

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

Info on DTC Ad Brief Summaries Approved by OMB

10/22/2007

Federal Register Notice: FDA’s collection of information, “Experimental Evaluation of Variations in Content and Format...

Comments Extended on Electronic Package Insert

10/22/2007

Federal Register Notice: FDA is reopening to 12/6 the comment period for the 4/2 Federal Register notice related to a 4/27 public ...

Panel to Discuss Astellas Pharma and Solvay NDAs

10/18/2007

Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 12/11-12, from 8 a.m. to 5 p.m. a...

Panel Mulls Prestwick NDA for Chorea in Huntington’s

10/18/2007

Federal Register Notice: FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet 12/6, from 8 a.m. to...

Science Board Meeting Date Changed

10/18/2007

Federal Register Notice: FDA is amending a 10/2 notice of meeting of the Science Board to the Food and Drug Administration. The me...

Sole Drug Manufacturers Must Notify Before Discontinuing

10/18/2007

Federal Register Final rule: FDA is amending its regulations describing postmarketing reporting requirements to require an applica...

FDA Proposes Change on Live Vaccine Processing Regs

10/18/2007

Federal Register Proposed rule and direct final rule: FDA is proposing to amend the biologics regulations by providing options to ...

OMB OKs Special Protocol Assessment Info

10/18/2007

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Special Protocol Assessmen...

CDER Seeks Firms for Site Tour Program

10/17/2007

Federal Register Notice: CDER is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Intera...