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GUIDANCE DOCUMENT

E12A Principles for Clinical Evaluation of New Antihypertensive Drugs August 2000

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2000-D-0785
Issued by:
Guidance Issuing Office
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 required.

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All written comments should be identified with this document's docket number: FDA-2000-D-0785.

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