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M4: The CTD -- Quality Questions and Answers /Location Issues June 2004

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This is one in a series of guidances that provide recommendations for applicants preparing the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for submission to the U.S. Food and Drug Administration (FDA). The guidance for industry issued in November 2000 on preparing the CTD was divided into four separate documents: (1) M4: Organization of the CTD, (2) M4: The CTD — Quality, (3) M4: The CTD — Efficacy, and (4) M4: The CTD — Safety. Since implementation of these guidances, a number of questions regarding the CTD documents have been submitted to the various ICH regions. The ICH has developed a process for responding to questions submitted to the ICH Web site. This guidance specifically addresses questions related to quality. Other question and answer (Q & A) guidances address general questions as well as questions related to safety and efficacy. The questions and answers provided here reflect the consensus of the ICH parties.

Submit Comments

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-2002-D-0261.

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