Komal Karnik Nigam on Prescription Drugs

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’s creation of public database of 200 Complete Response letters raises questions

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

7/11/2025 / Biotechnology , Disclosure Requirements , Food and Drug Administration (FDA) , Investors , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Requirements , Securities Litigation

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

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

FDA Finalizes Guidance for Communications About Unapproved Uses to HCPs, Clarifying Multiple Standards

The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more

1/22/2025 / Food and Drug Administration (FDA) , Health Care Providers , Marketing , Medical Devices , Pharmaceutical Industry , Prescription Drugs

FDA announces public meeting on pediatric exclusivity and drug development

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act”...more

1/17/2025 / Food and Drug Administration (FDA) , Labeling , Medical Research , Pediatrics , Pharmaceutical Industry , Prescription Drugs , Regulatory Agenda , Research and Development

Safe harbor for voluntary corrections of drug or device “misinformation” clarified in FDA guidance

The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their...more

7/18/2024 / Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry , Prescription Drugs

Eleventh Circuit decision could significantly expand scope of orphan exclusivity

With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity for Catalyst Pharmaceuticals, Inc....more

2/2/2022 / FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs

FDA finalizes guidance on Orphan Drug “sameness” of gene therapies

Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations,” which...more

10/1/2021 / Food and Drug Administration (FDA) , Life Sciences , New Guidance , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs

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

Komal Karnik Nigam

Hogan Lovells

Popular Topics by This Author

Latest Posts › Prescription Drugs