Komal Karnik Nigam

Komal Karnik Nigam

Hogan Lovells

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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 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

White House issues Executive Order directing efforts to lower drug prices

On April 15, 2025, the White House issued an Executive Order (EO) entitled “Lowering Drug Prices by Once Again Putting Americans First.” The EO directs various agencies to engage in a number of distinct efforts to lower...more

4/18/2025  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Medicaid , Medicare , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Trump Administration

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

8/22/2017  /  Abbreviated New Drug Application (ANDA) , Biotechnology , Drug Design , Drug Pricing , FDARA , FDASIA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Generic Drugs , Innovation , Medical Devices , New Legislation , Orphan Drugs , PDUFA , Pediatrics , Prescription Drugs , Product Labels , Regulatory Oversight , Trump Administration , User Fees
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