Guidances > Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov1. All comments should be identified with the docket number (FDA-2010-D-0530) listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact:

Ritu Nalubola, Ph.D.,
Office of Policy
Office of the Commissioner,
Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993,
301-796-4830
Ritu.Nalubola@fda.hhs.gov

Or

Carlos Peña, Ph.D.,
Office of the Chief Scientist,
Office of the Commissioner,
Food and Drug Administration,
10903 New Hampshire Avenue,
Silver Spring, MD 20993,
301-796-4880
Carlos.Pena@fda.hhs.gov

U.S. Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner

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Guidances > Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology