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• Draft guidance on medical products to treat radiation contamination.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 Draft Guidance for Industry: Internal Radioactive Contamination —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• Draft Guidance for Industry: Vaccinia Virus -- Developing Drugs to Mitigate Complications from Smallpox Vaccination.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• Draft Guidance for Industry on Developing Drugs to Treat Inhalational Anthrax (Post-Exposure) (Issued and posted 3/18/2002) 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