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M4E(R2): The CTD – Efficacy July 2017

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 or Agency). A common format for technical documentation significantly reduces the time and resources needed to compile applications for registration of human pharmaceuticals by eliminating the need for applicants to reformat data and information for submission to multiple regulatory authorities. This harmonization facilitates regulatory reviews, efficient communication between regulators and applicants, as well as the efficient exchange of information between regulatory authorities.

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.