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GUIDANCE DOCUMENT

Q1C Stability Testing for New Dosage Forms May 1997

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-S-0610
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This document is an annex to the ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and Products and addresses the recommendations on what should be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new drug substances and products.

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All written comments should be identified with this document's docket number: FDA-2013-S-0610.

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