Regulatory Information for Counter-Terrorism Drug Development
- FDA News: Draft guidance on medical products to treat radiation contamination.
Guidance for Industry: Internal Radioactive Contamination - Development of Decorporation Agents (PDF - 177KB) (Posted 3/2006).
- Draft Guidance for Industry: Vaccinia Virus - Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF - 139KB) (Issued 3/2004, Posted 3/8/2004).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 News: FDA amends its regulation to provide for approval of certain new pharmaceutical products based on animal efficacy data. (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 - 53KB)
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- Draft Guidance for Industry on Developing Drugs to Treat Inhalational Anthrax (Post-Exposure) (PDF - 52KB) (Issued and posted 3/18/2002)