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Do the Waive – FDA Implements Informed Consent Waivers for Minimal Risk Studies

August 10, 2017

To certify or not to certify? FDA has answered the question

June 13, 2017

Ready, Set… Cures Act Expanded Access Policy Deadline is Almost a Go

February 8, 2017

Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act

December 16, 2016

California Tries the “Right to Try” Act — FDA’s Expanded Access Regulations Remain in Force

September 29, 2016

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

September 22, 2016

FDA June 2, 2016 Final Guidances For Industry

June 13, 2016

Federal Court Determines that Patient Has Liberty Interest in Receiving Investigational Drug

May 24, 2016

FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations

May 19, 2016
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Justin Yu

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