Jason Conaty

Hogan Lovells

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Latest Posts › Drug Approvals

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FDA adds information on Commissioner’s National Priority Voucher program

This week, the U.S. Food and Drug Administration (FDA) posted additional information on its recently announced “Commissioner's National Priority Voucher” (CNPV) program, which will provide up to five vouchers in the program's...more

7/23/2025 / Biologics , Clinical Trials , Drug Approvals , Drug Pricing , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Public Health , Regulatory Authority , Regulatory Reform

FDA launches “Elsa” AI tool to aid drug approvals

The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more

6/13/2025 / Algorithms , Artificial Intelligence , Clinical Trials , Drug Approvals , Food and Drug Administration (FDA) , Machine Learning , Pharmaceutical Industry , Prescription Drugs , Regulatory Agencies , Regulatory Oversight

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

8/13/2021 / Biotechnology , Drug Approvals , Drug Compounding , FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Genus , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Public Comment

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