Volume 7, Number 6—December 2001
Perspective
Developing New Smallpox Vaccines
Steven R. Rosenthal
, Michael Merchlinsky, Cynthia Kleppinger, and Karen L. Goldenthal
, Michael Merchlinsky, Cynthia Kleppinger, and Karen L. GoldenthalTable 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 http://www.fda.gov/cber/guidelines.htm or call the FDA Office of Communication, Training and Manufacturers Assistance at 1-800-835-4709.
