Drug Information

Analgesia & Anti-inflammatory
Drug Development Guidance

Guidances Currently Available

• Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA) [HTML] or [PDF] (Issued 1/1999, Posted 2/16/1999)
  • Background information on this guidance
• Clinical Evaluation of Analgesic Drugs (Withdrawn per August 5, 2003, Federal Register Notice) 
• Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children)

Draft Guidances

• Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis [HTML],  [PDF] or [WORD] (Issued 7/07/1999, Posted 7/14/1999)
• Pharmacogenomic Data Submissions [Word] or [PDF] (Issued 11/2003)

Arthritis  Drugs Advisory Committee Meeting Information

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FDA/Center for Drug Evaluation and Research
Last Updated: August 1, 2005
Originator: OTCOM/DLIS
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