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Regulatory Reform Food and Drug Administration (FDA) Prescription Drugs

Carlton Fields

Agency Actions, Trade Deals, and Other Initiatives to Further Executive Order Goals for the Pharma Industry

Carlton Fields on

The Trump administration has issued numerous pharma-focused executive orders, including “Lowering Drug Prices by Once Again Putting Americans First,” “Regulatory Relief to Promote Domestic Production of Critical Medicines,”...more

McDermott+

Trump Administration Executive Order Tracker

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

McDermott Will & Schulte

A need for speed: FDA piloting voucher program to expedite drug review

On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more

Hogan Lovells

FDA adds information on Commissioner’s National Priority Voucher program

Hogan Lovells on

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

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

Ropes & Gray LLP on

On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

Holland & Knight LLP

Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

Holland & Knight LLP on

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more

Foley & Lardner LLP

FDA: Commissioner’s National Priority Voucher Program Aims to Streamline Some Drug Reviews

Foley & Lardner LLP on

Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...more

Latham & Watkins LLP

Senators Introduce Legislation to Restrict Direct-to-Consumer Drug Advertising

Latham & Watkins LLP on

On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

Troutman Pepper Locke on

On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

Benesch

AI Reporter - June 2025

Benesch on

The FDA began integration of generative AI across all its centers, a project that should be completed by the end of June. Newly appointed chief AI officer, Jeremy Walsh, and Office of Strategic Programs at CDER, Sridhar...more

Wilson Sonsini Goodrich & Rosati

FDA Announces “Priorities for a New FDA” and a New Vouchers Program to Address National Priorities

On June 10, 2025, FDA Commissioner Martin A. Makary and Chief Medical and Science Officer Vinay Prasad published an article in the Journal of the American Medical Association titled, “Priorities for a New FDA.”1 The article...more

Husch Blackwell LLP

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

Husch Blackwell LLP on

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

Knobbe Martens

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

Knobbe Martens on

The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more

Holland & Knight LLP

U.S. Pharmaceutical Manufacturing and Supply Chain: 2025 Risks, Opportunities for Stakeholders

Holland & Knight LLP on

The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more

Hogan Lovells

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

Hogan Lovells on

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

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Commissioner Launches Pilot Program To Speed Review of Certain Drugs

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

Katten Muchin Rosenman LLP

FDA Reimagined: Faster, Friendlier, and Focused on Cures

On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics Evaluation and Research, published an article in JAMA discussing the “Priorities for a...more

McDermott Will & Schulte

GLP-1 Update: Court Backs FDA in Tirzepatide Compounding Case

On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more

Mintz - Health Care Viewpoints

FDA in Flux — June 2025 Newsletter

Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Bradley Arant Boult Cummings LLP

Makary Says Psychedelics Are Maybe Okay, M’Kay?

Drugs are bad, m’kay. But what if they’re not? Psilocybin continues to be in the limelight for its potential medicinal uses, including most particularly its potential to combat the nation’s growing mental health crisis. Last...more

Knobbe Martens

Executive Order 14297 and the Global Drug Market: Policy, Pricing, and Uncertainty

Knobbe Martens on

On May 12, 2025, President Trump issued Executive Order 14297 targeting prescription drug prices in America. The stated purpose of this order is to combat high drug prices in the United States, bringing the prices Americans...more

Holland & Knight LLP

Food and Chemical Regulatory Update: The Make Our Children Healthy Again Assessment

Holland & Knight LLP on

The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Ropes & Gray LLP

Executive Order Calls for Most-Favored-Nation Pharmaceutical Pricing for American Patients

Ropes & Gray LLP on

On May 12, 2025, President Trump issued an executive order (the “Executive Order”) directing executive agencies and, imminently, pharmaceutical manufacturers to take steps to deliver most-favored-nation (“MFN”) prescription...more

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