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FDA OKs Merial NADA for Equine Osteoarthritis

[ Price : $8.95]

Federal Register Final rule: FDA approves a Merial Ltd. NADA for veterinary prescription use of firocoxib injectable for equine os...

Committee Wants Pediatric Medicine Recall Answers

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The House Oversight and Government Reform Committee expects explicit answers from Johnson & Johnson officials at a 9/30 hearing on...

FDA Sends Info on New Animal Drugs for Minor Use/Species to OMB

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Federal Register Notice: FDA submits a proposed collection of information, Designated New Animal Drugs for Minor Use and Minor Spe...

Special Controls Guidance on HSV Assays

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Federal Register Notice: FDA releases a draft guidance entitled, Class II Special Controls Guidance Document: Herpes Simplex Virus...

Panel to Discuss Postmarket Studies of OxyContin, Embeda

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Federal Register Notice: FDAs Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisor...

Safety Reporting Guidance Out

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FDA issues a guidance on safety reporting requirements for INDs and BA/BE studies.

Limit Patient Info Sheets to FDA-approved Data: Consumer Reps

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Consumer groups say patient medication information sheets should only contain data that have been reviewed by FDA.

FDA Confirms Effective Date on HSV Assays Rule

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Federal Register Direct final rule: FDA confirms the effective date of a final rule correcting the regulation classifying herpes s...

FDA Proposes to Amend HSV Assay Special Controls

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Federal Register Proposed rule: FDA proposes to amend the special controls for the herpes simplex virus (HSV) serological assay de...

Panel to Discuss Infant GERD Trial Results

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Federal Register Notice: FDAs Gastrointestinal Drugs Advisory Committee will meet 11/5 to discuss the results from clinical trials...