FDA Form 1572 - Guidance on the FDA's Statement of Investigator Form

 In July 2008, FDA released a draft guidance to answer frequent questions about Form FDA-1572, also called the Statement of Investigator form. A Food and Drug Administration Guidance is non-binding, but it does serve as useful information on how to interpret the agency's regulations. Keep in mind that this is only a draft; with the recent change in administration this draft may never be released as final or it may be significantly modified.

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FDA’s Bioresearch Monitoring (BIMO) Inspections

FDA BIMO inspections, Form 483 and Warning Letter

BIMO, the Bioresearch Monitoring Program, is a Food and Drug Administration (FDA) program of on-site inspections to ensure the quality and integrity of the data submitted to the agency from regulated clinical trials of investigational drugs, devices, and biologics. Inspections are made both in the U.S. and internationally at clinical investigator sites, institutional review boards (IRBs), and sponsors (e.g., pharmaceutical, medical device, and biologic companies, including monitors and contract research organizations or CR0s working under the sponsor).

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