News & Analysis as of

National Security Food and Drug Administration (FDA) Pharmaceutical Industry

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

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

Morgan Lewis

From Offshore to Onshore: Considerations for Pharmaceutical Industry Stakeholders Amid New Domestic Drug Manufacturing EO

Morgan Lewis on

The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...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

Morgan Lewis - As Prescribed

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more

Foley Hoag LLP

U.S. Department of Commerce Investigates Possible Tariffs on Pharmaceuticals: Forecasting the Impact and an Opportunity to Comment

Foley Hoag LLP on

I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more

Skadden, Arps, Slate, Meagher & Flom LLP

CARES Act Provides Much-Needed Stimulus for U.S. Businesses, Individuals

On March 27, 2020, Congress approved the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide financial assistance to individuals and businesses, which in aggregate greatly exceeds the financial package...more

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