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Tag: guidance

Man’s wrist sitting on table with medical barcode bracelet from hospital stay

Guidance on Future Research Authorizations from the HHS

The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued a Read More »

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Extension of the Effective Date of the Single IRB Policy for NIH Studies

As announced in the July edition of Focus, the National Institutes of Health (NIH) has Read More »

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Important Updates to Common Rule for Clinical Trials

U.S. Department of Health and Human Services (DHHS) and 15 other federal agencies on January Read More »

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Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research

The National Institutes of Health (NIH) has released a new policy, effective in 2017, to Read More »

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FDA Finalizes Three Guidances on Expanded Access to Investigational Drugs

Expanded access is the process by which investigational treatment options are made available to patients Read More »

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