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Final Rules 21st Century Cures Act Clinical Trials

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

Foley & Lardner LLP

FDA’s Response to HHS’ Revised Common Rule: Four Things to Know

Foley & Lardner LLP on

In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

Verrill on

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

Hogan Lovells

HHS Overhauls the Common Rule to Enhance Protection for Human Subjects in Research

Hogan Lovells on

On 18 January 2017, as one of the last actions of the outgoing Obama Administration, the U.S. Department of Health and Human Services (HHS) and fifteen other federal agencies (the Agencies) issued a final rule overhauling the...more

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