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E12A Principles for Clinical Evaluation of New Antihypertensive Drugs August 2000


Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

This document provides general principles for the clinical evaluation of new anti- hypertensive
drugs. It  describes  core  principles  for  the  evaluation of antihypertensives that are
accepted in the three ICH regions, but some region-specific differences remain. These differences
may be harmonized in future, but it is important  at present to refer to existing regional
guidelines and to discuss the specific  requirements with regional regulatory authorities, if

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.