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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 Read the Federal Register Notice
Final
Docket Number:
FDA-2008-D-0391
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Biologics Evaluation and Research
Center for Drug 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.

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All written comments should be identified with this document's docket number: FDA-2008-D-0391.

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