Audrey Mercer

Jan 14, 2025 | jdsupra.com | Dominick DiSabatino |Audrey Mercer

[co-author: Julian Klein*]On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft Guidance”).

Dec 20, 2024 | jdsupra.com | Audrey Mercer

[co-author: Julian Klein*] On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and Biologics Guidance for Industry” (the “Draft Guidance”).[1] FDA’s so-called “accelerated approval” program is designed to expedite the development and review of new drugs and/or biologics that fulfill unmet medical needs for serious or...

Dec 17, 2024 | jdsupra.com | Audrey Mercer

This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration (“FDA” or the “Agency”) final rule in May, which established a staged plan that will phase out FDA’s previous policy of enforcement discretion for LDTs; second, the overturn of the Chevron Doctrine in Loper v.

Dec 10, 2024 | mondaq.com | Cheese Consumers |Dominick DiSabatino |Audrey Mercer

Earlier this week, the U.S. Food & Drug Administration ("FDA" or the "Agency") released its long-anticipated final guidance (the "Guidance") on predetermined change control plans ("PCCPs") for devices that utilize artificial intelligence/machine learning ("AI/ML") software.

Dec 6, 2024 | jdsupra.com | Dominick DiSabatino |Audrey Mercer

Earlier this week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) released its long-anticipated final guidance (the “Guidance”) on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence/machine learning (“AI/ML”) software.