Jason Conaty

Jason Conaty

Hogan Lovells

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FDA Commissioner’s National Priority Voucher program comes with questions surrounding implementation

The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more

6/19/2025  /  Clinical Trials , Drug Pricing , Food and Drug Administration (FDA) , New Guidance , New Regulations , Pharmaceutical Industry , Prescription Drugs , Public Health , Regulatory Oversight , Regulatory Reform

FDA animal testing phaseout urges AI-based trial alternatives, organoids, other “NAMs”

The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective,...more

5/7/2025  /  Animal Testing , Artificial Intelligence , Biotechnology , Clinical Trials , Food and Drug Administration (FDA) , Machine Learning , Pharmaceutical Industry , Regulatory Reform , Regulatory Requirements

FDA Reduction-In-Force expected to impact drug & biologic review and regulation, other operations

Last week, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced an impending reduction in force (RIF) of approximately 10,000 positions, including about 3,500 Food and Drug Administration (FDA)...more

4/3/2025  /  Department of Health and Human Services (HHS) , Employees , Food and Drug Administration (FDA) , Government Agencies , Hiring & Firing , Layoffs , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Regulatory Requirements

Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. ...more

4/27/2021  /  Biosimilars , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , New Legislation , Pharmaceutical Industry , Prescription Drugs , Product Exclusivity , Regulatory Reform

New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and exclusivity-related information for approved drugs listed...more

1/21/2021  /  Biologics , Food and Drug Administration (FDA) , Life Sciences , New Legislation , Orange Book , Patents , Pharmaceutical Patents , Purple Book , Regulatory Reform , Transparency
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