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Volume 7, Number 6—December 2001


Developing New Smallpox Vaccines

Steven R. RosenthalComments to Author , Michael Merchlinsky, Cynthia Kleppinger, and Karen L. Goldenthal
Author affiliations: Food and Drug Administration, Rockville, Maryland, USA

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Table A2

Examples of ICH Documents Relevant to Clinical Testing of Vaccines

Title Date
Good clinical practice: Consolidated guideline 1997
General considerations for clinical trials 1997
Structure and content of clinical study reports 1996
Statistical principles for clinical trials (draft) 1997

To obtain these documents, connect to or call the FDA Office of Communication, Training and Manufacturers Assistance at 1-800-835-4709.

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