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Assessment of Male- Mediated Developmental Risk for Pharmaceuticals Guidance for Industry - PharmaFacts
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Assessment of Male- Mediated Developmental Risk for Pharmaceuticals Guidance for Industry

Assessment of Male-

Mediated Developmental

Risk for Pharmaceuticals 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DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 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 Lynnda Reid at 301-796-0984.

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

June 2015 Pharmacology and Toxicology

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17325dft.doc 06/01/15

 

Assessment of Male-

Mediated Developmental

Risk for Pharmaceuticals Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993
Tel: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

June 2015 Pharmacology and Toxicology

Click HERE for full Guidance