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Regulatory Reform Food and Drug Administration (FDA)

Akin Gump Strauss Hauer & Feld LLP

Citizen Petition Calls on FDA to Rethink Refined Carbs

Last week, former Food and Drug Administration (FDA) Commissioner David Kessler submitted a citizen petition urging FDA to revoke the generally recognized as safe (GRAS) status of refined carbohydrates used in industrial food...more

Wiley Rein LLP

FDA’s Proposed Ranking Tool Gives Public Opinion a Seat at the Food Safety Table

Wiley Rein LLP on

With food policy remaining a top priority for the Trump Administration, the U.S. Food and Drug Administration (FDA), acting under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., has swiftly advanced a number...more

Katten Muchin Rosenman LLP

Fast-Lane Approval to Boost U.S. Drug Manufacturing and Supply Chain Security

On August 7, 2025, the Food and Drug Administration announced a voluntary “FDA Pre-Check” program to encourage and expedite domestic drug manufacturing by offering qualifying facilities a more predictable, risk-based...more

Morgan Lewis - As Prescribed

FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

Foley Hoag LLP on

Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

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

DLA Piper

Food and Beverage News and Trends - August 2025

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....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

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

Epstein Becker & Green on

Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...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

K&L Gates LLP

Microplastics Under the Microscope: Federal and California Proposals Target Microplastics

K&L Gates LLP on

On 17 July 2025, a bipartisan bill aimed at uncovering the potential human health implications of exposures to microplastics in the food and water supply was introduced into Congress. Introduced by Rep. Janelle Bynum (D-OR),...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

Morrison & Foerster LLP

FDA Targets 52 “Obsolete” Food Standards of Identity for Revocation

On July 17, 2025, FDA announced several rulemakings aimed at modernizing its standards of identity (SOIs) for food products – regulations that define what a food must contain and how it must be made to lawfully bear a...more

Hogan Lovells

FDA Proposes Revoking Standards of Identity for 52 Food Products

Hogan Lovells on

On July 16, 2025, the U.S. Food and Drug Administration (FDA) announced plans to revoke the standards of identity for 52 food products the agency characterizes as obsolete. To do this, FDA has issued three proposed rules and...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

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

Foley & Lardner LLP on

The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more

Perkins Coie

SAFE Sunscreen Standards Act: Bipartisan Push to Modernize U.S. Sunscreen Regulation

Perkins Coie on

On June 3, 2025, lawmakers introduced the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act in the U.S. House of Representatives, aiming to bring U.S. sunscreen regulations in line with scientific...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

Shook, Hardy & Bacon L.L.P.

Think Tank Argues for Closing GRAS Loophole

U.S. policymakers should consider reforms to close loopholes surrounding Generally Recognized as Safe (GRAS) substances, according to an issue brief from the America First Policy Institute. The report recommends against...more

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

Morgan Lewis on

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

Sheppard Mullin Richter & Hampton LLP

What’s Going on with Human Cell and Tissue Products?

Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same....more

Vicente LLP

Texas Cannabis Legalization: What the SB 3 Veto Means for Hemp Businesses - UPDATED

Vicente LLP on

What is Texas Senate Bill 3? As it stands, current Texas law permits hemp-derived products with less than 0.3% THC content, which are widely available at more than 8,000 locations throughout the state. In comparison to a...more

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