News & Analysis as of

Public Health Regulatory Reform 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

McDermott+ on

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

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

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

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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2025 #4

News Briefs - Judge Rules Against Administration's HHS Reorg, Reductions - California District Judge Susan Illston has granted a preliminary injunction against the Trump administration's recent reductions in force across...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

Morgan Lewis - As Prescribed

Conditional Approval Proposals for FDA: Current Context and Potential Ramifications

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders...more

Skadden, Arps, Slate, Meagher & Flom LLP

Makary Is Confirmed as Commissioner of an FDA in Transition

Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

Bennett Jones LLP on

Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

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