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Guidance on Repeat-Dose Veterinary Drug Toxicity

02/07/2005

Federal Register Notice: FDA is making available a guidance document for industry entitled Studies to Evaluate the Safety of Resid...

Public Meeting on Animal Feed Safety

02/07/2005

Federal Register Notice: FDA will hold a public meeting 4/5-6 to discuss its progress in developing a comprehensive, risk-based An...

Oncologic Drugs Panel to Discuss Combidex, Iressa

02/04/2005

Federal Register Notice: FDA will hold a meeting of the Oncologic Drugs Advisory Committee 3/3, from 8 a.m. to 5 p.m. and 3/4, fro...

FDA Proposes Withdrawal of 13 NDAs

01/28/2005

Federal Register Notice: FDA is announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 new dr...

Panel to Discuss Bristol-Myers Squibb Hepatitis B NDAs

01/28/2005

Federal Register Notice: FDA’s Antiviral Drugs Advisory Committee will meet 3/11, from 8 a.m. to 5 p.m. at the Hilton Washin...

Guidance on Nonclinical Drug Safety Evaluation

01/26/2005

Federal Register Notice: FDA is making available a draft guidance for industry entitled Nonclinical Safety Evaluation of Drug Comb...

Info on Dispute Resolution Sent to OMB

01/26/2005

Federal Register Notice: FDA’s proposed collection of information, “Draft Guidance for Industry on Formal Dispute Reso...

Panel to Discuss Atacand sNDAs

01/24/2005

Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 2/24, from 8 a.m. to 5 p.m. at th...

Changes Made to Orphan Products Grants Program

01/14/2005

Federal Register Notice: FDA is making changes to its Office of Orphan Products Development grant program for fiscal year 2006. Th...

FDA OKs Ivy Labs ANADA for Heifer Feed

01/14/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an abbreviated new animal drug app...