Regulatory Oversight, Food and Drug Administration (FDA), Drug Pricing

FDA Launches Commissioner’s National Priority Voucher Program: What Life Sciences Innovators Need to Know

Husch Blackwell LLP on 6/24/2025

On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more

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

Hogan Lovells on 6/19/2025

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

FDA Commissioner Launches Pilot Program To Speed Review of Certain Drugs

Skadden, Arps, Slate, Meagher & Flom LLP on 6/18/2025

On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV). The program is intended...more

Five FDA Takeaways from the FY26 Budget

Akin Gump Strauss Hauer & Feld LLP on 6/3/2025

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

Morgan Lewis on 4/7/2025

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

Tillis Urges FDA, USPTO to Investigate Potential False Narrative by Drug Critics

Jones Day on 2/16/2022

On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more

Special Report: FDA 2019 Year in Review

McDermott Will & Schulte on 1/14/2020

The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more

[Event] Rx Drug Advertising and Promotion Executive Think Tank – Embrace this New Era of Advertising with Creative and...

American Conference Institute (ACI) on 11/6/2019

ACI is delighted to present our inaugural Think Tank on Rx Drug Advertising and Promotion. Attend this intimate and in-depth symposium where the “who’s who” of pharmaceutical advertising and promotion will gather to discuss...more

Regulatory Oversight › Food and Drug Administration (FDA) › Drug Pricing

FDA Launches Commissioner’s National Priority Voucher Program: What Life Sciences Innovators Need to Know

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

FDA Commissioner Launches Pilot Program To Speed Review of Certain Drugs

Five FDA Takeaways from the FY26 Budget

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

Tillis Urges FDA, USPTO to Investigate Potential False Narrative by Drug Critics

Special Report: FDA 2019 Year in Review

[Event] Rx Drug Advertising and Promotion Executive Think Tank – Embrace this New Era of Advertising with Creative and...

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

Will FDA be forced to implement a drug importation program?

CMS proposes requiring drug prices in TV ads

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

Regulatory Oversight › Food and Drug Administration (FDA) › Drug Pricing

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