U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Prussian Blue Drug Products — Submitting a New Drug Application
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Prussian Blue Drug Products — Submitting a New Drug Application February 2003

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2003-D-0727
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist manufacturers wishing to submit new drug applications (NDAs) for prussian blue drug products for the treatment of internal contamination with radioactive thallium, nonradioactive thallium, or radioactive cesium. The Federal Register notice announcing the availability of this guidances explains in detail the Agency's findings regarding safety and effectiveness and includes a list of the literature on which it based those findings.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2003-D-0727.

 
Back to Top