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Food and Drug Administration (FDA) Pharmaceutical Industry Department of Defense (DOD)

Blank Rome LLP

Domestic Production of Pharmaceuticals: Are the Administration’s Efforts Enough?

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The Administration issued Executive Order (“EO”) 14293: Regulatory Relief to Promote Domestic Production of Critical Medicines on May 5, 2025...more

Perkins Coie

BARDA Shares Details About Innovative BioMaP Consortium at BARDA Industry Day 2023

Perkins Coie on

The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more

Axinn, Veltrop & Harkrider LLP

Biden Administration Promotes Domestic Pharmaceutical Production to Reduce Drug Shortages

I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more

Venable LLP

DOD-FDA Enhanced Engagement to Accelerate the Development of Medical Products for Our Military Personnel

Venable LLP on

Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more

Akin Gump Strauss Hauer & Feld LLP

America’s Pharmaceutical Supply Chain: An Overview of the Policy Landscape and Potential Path Forward

For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical...more

Haug Partners LLP

When the “States” Come Marching-In: The Bayh-Dole Act’s Effect on IP Rights of COVID-Related Patents and Knowledge Ecology...

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On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

Hogan Lovells

Buy American EO applies domestic preferences for "essential medicines" and "medical countermeasures"

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On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Hogan Lovells

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general...

Hogan Lovells on

On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement Public Law...more

K&L Gates LLP

FDA and DoD Launch Priority Development Program for Medical Products Essential for the Urgent Care of U.S. Military Personnel

K&L Gates LLP on

On January 16, 2018, the U.S. Food and Drug Administration (FDA) and the Department of Defense’s (DoD) Office of Health Affairs (“Health Affairs”) launched a joint program to help expedite the development and availability of...more

Hogan Lovells

New Legislation Increases Access to Medical Products for Military Applications

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Yesterday, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products...more

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