Presentation by Stan Woolen of FDA

FDA presentation slides ” Computerized Systems used in clinical trials” given by Stan W. Woollen May 27, 1999 at the ACRP annual meeting. This presentation addressed U.S. FDA 21 CFR Part 11 and the FDA guidance for Computerized Systems used in clinical trials and discussed their interrelationships.

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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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