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GUIDANCE DOCUMENT

Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality Guidance for Industry June 2013

Download the Final Guidance Document
Final
Docket Number:
FDA-2012-D-0083
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Devices and Radiological Health

This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the potential risk of crude heparin contamination.

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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-2012-D-0083.

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