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Drugs
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Regulatory Information for Counter-Terrorism Drug Development
- Draft guidance on medical products to treat radiation contamination. FDA News. Draft Guidance for Industry: Internal Radioactive Contamination —
Development of Decorporation Agents [PDF] (Posted 2/14/2005)
- Draft Guidance for Industry: Vaccinia Virus -- Developing Drugs to Mitigate Complications from Smallpox Vaccination. [PDF] (Issued 3/2004, Posted 3/8/2004). FDA News.
- Calcium-DTPA and Zinc-DTPA. The FDA encourages manufacturers to submit new drug applications (NDAs) for Ca-DTPA and Zn-DTPA drug products. (Posted 9/12/2003)
- FDA amends its regulations to provide for approval of certain new pharmaceutical products based on animal efficacy data. FDA News. (Posted 6/3/2002)
- Safety and Effectiveness of Products for the Treatment of Naturally Occurring Human Plague (Bubonic, Pneumonic, Meningitic, or Septicemic); Availability of Grants; Request for Applications. Optional Format: PDF The application receipt date is July 29, 2002. (Posted 6/4/2002)
- Draft Guidance for Industry on Developing Drugs to Treat Inhalational Anthrax (Post-Exposure) (Issued and posted 3/18/2002)
- Federal Register notice: Optional Format: PDF
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