Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Adverse Event Repo

• Date: November 09, 2009
• Source: www.fda.gov

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach ifthe approach satisfies the requirements ofthe applicable statutes and regulations. If you want to discuss an alternative approach, contact
the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriatetelephone number listed on the title page ofthis guidance.

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