To certify or not to certify? FDA has answered the question
Ready, Set… Cures Act Expanded Access Policy Deadline is Almost a Go
Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act
California Tries the “Right to Try” Act — FDA’s Expanded Access Regulations Remain in Force
FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
FDA June 2, 2016 Final Guidances For Industry
Federal Court Determines that Patient Has Liberty Interest in Receiving Investigational Drug
FDA Clarifies Expectations for Use of Electronic Health Records in Clinical Investigations
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