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Article

Dechert LLP | USA | 19 Sep 2011

FDA issues draft guidance on informed consent language

The FDA has issued draft guidance on the use of "Exculpatory Language in Informed Consent" agreements.

Article

Reed Smith LLP | USA | 27 Jan 2009

Clinical investigator financial disclosure

The HHS Office of Inspector General (OIG) has issued a report on “The Food and Drug Administration's Oversight of Clinical Investigators' Financial Information,” which concludes that clinical investigators may not be disclosing all financial interests.

Article

Hogan Lovells | USA | 13 Jan 2009

HHS Office of Inspector General issues report critical of FDA’s oversight of clinical investigators’ financial disclosure

On January 12, 2009, the Department of Health and Human Services Office of Inspector General (OIG) issued a report that was deeply critical of the U.S. Food and Drug Administration’s (FDA) oversight of clinical investigators’ financial disclosure.

Article

McDermott Will & Emery | USA | 3 Nov 2008

Developments in Medicare payment for services in clinical trials

Providers and research sponsors must consider two recent Medicare-related administrative issuances indicating CMS and OIG interpretations regarding provisions of clinical trial arrangements and Medicare payment for routine cost services in clinical trials.

Article

Hogan Lovells | USA | 28 Jan 2008

New reporting obligations under Medicare secondary payer law may have implications for sponsors of clinical trials

On December 29, 2007, President Bush signed the Medicare, Medicaid, and SCHIP Extension Act of 2007 (the Act).

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