News & Analysis as of

Supply Chain Food and Drug Administration (FDA) Regulatory Reform

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

Morgan Lewis - Well Done

FDA Proposes New Tool for Post-Market Scientific Assessment of Food Ingredients

On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including...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

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

Sheppard Mullin Richter & Hampton LLP

Onshoring Pharma Ops: Reading Recent EO and Policy Tea Leaves

Recently, underscoring a commitment to national security, the White House and the Food and Drug Administration (FDA) issued separate communications that aim to bolster domestic drug manufacturing while tightening oversight of...more

King & Spalding

New Executive Order Promotes Domestic Production of Critical Medicines

King & Spalding on

On May 5, 2025, President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of Critical Medicines. The EO directs the U.S. Food and Drug Administration (“FDA”), U.S....more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Carlton Fields

Regulatory Relief to Promote Domestic Production of Critical Medicines

Carlton Fields on

President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical...more

Akin Gump Strauss Hauer & Feld LLP

The Trump Administration Seeks to Spur Domestic Drug Manufacturing with Regulatory Relief EO

On May 5, President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines,” with the stated purpose of eliminating “regulatory barriers to the domestic production...more

Hogan Lovells

Reshoring EO aims to streamline permitting, approval, and oversight of US drug manufacturing

Hogan Lovells on

On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles,...more

Jones Day

FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers

Jones Day on

The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more

Morgan Lewis

What the Future May Hold for Pharma Regulation Under the Biden Administration

Morgan Lewis on

Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more

Seyfarth Shaw LLP

New Federal Contract Reporting Requirements Aimed at Protecting Supply Chains Through Detection of Counterfeit Parts

Seyfarth Shaw LLP on

Federal contractors already subject to a myriad of reporting requirements should be prepared for yet another. Effective December 23, 2019, a new Federal Acquisition Regulation (“FAR”) provision entitled “Reporting of...more

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