Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

[Trial of device that is not approved or cleared by the U.S. FDA]

This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.
Information provided by:
[Redacted] Identifier:
First received: April 7, 2010
Last updated: February 9, 2015
Last verified: NA

Responsible Party: [Redacted] Identifier: NCT01100190     History of Changes
Other Study ID Numbers: 200-08-001
Study First Received: April 7, 2010
Last Updated: February 9, 2015
Health Authority: Israel: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Ethics Commission
United Kingdom: Research Ethics Committee processed this record on March 02, 2015

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