Here is your pdf: Drug Products, Including Biological Products, that Contain Nanomaterials – Guidance for Industry

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Access date: 2019-04-10 14:00:26.494519

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The content is as follows:

17050 draft

Drug Products,

Including Biological

Products, that Contain

Nanomaterials

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DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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

90 days

of

publication in the

Federal Register

of the notice announcing the availability of the draft

guidance.

Submit electronic comments to

https://www.regulations.gov

. Submit

written

comments to the Dockets Management

Staff

(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 (CDER)

Katherine Tyner

301-796-0085, or

(CBER)

Office of Communication, Outreach and Development, 800

-835-4709 or 240

-402-8010.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Center for Biologics Evaluation and Research (CBER)

December

2017 Pharmaceutical Quality/CMC

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