Guidance for Industry Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention

Guidance for Industry Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention

DRAFT GUIDANCE
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269221.pdf
This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact Joseph G. Toerner, MD, MPH, at 301-7961300.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
August 2011
Clinical/Antimicrobial
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http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269221.pdf
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