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Investigational Device Exemptions Final Rules

Hogan Lovells

FDA Issues Final Guidance on Benefit-Risk Factors to Consider in Medical Device Product Availability, Compliance, and Enforcement...

Hogan Lovells on

On December 27, 2016, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled "Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement...more

Polsinelli

New Clinical Trial Rule Alters Reporting Requirements

Polsinelli on

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more

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