Thursday, August 23, 2012

New draft guidance being distributed by the FDA for comment purposes:

Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials (Revision 1)

This guidance revises the draft guidance issued in September 2010 regarding the prospective assessment of suicidality in clinical trials.

Comments and suggestions pertaining to this document should be submitted within 60 days of the notice announcing the availability of the draft guidance in the Federal Register.

Copies are available for download here.

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