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GUIDANCE DOCUMENT

Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes Guidance for Industry February 2010

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides recommendations to applicants on information to include in support of parametric release for sterile productsterminally sterilized by moist heat when submitting a new drug application (NDA), abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA), biologics license application (BLA), or supplement or other postmarketing report.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

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