News & Analysis as of

Manufacturers Research and Development

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

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....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

Baker Donelson

Opportunities for U.S. Manufacturers Under the Second Trump Administration

Baker Donelson on

Expanding on our prior alert, the next administration is expected to implement economic policies that will present significant opportunities for companies who make or want to make their products in the United States with...more

Bergeson & Campbell, P.C.

Biomanufacturing Interagency Working Group Identifies Actions to Increase U.S. Biomanufacturing Capacity

On November 15, 2024, the White House Office of Science and Technology Policy (OSTP) released a report by the Biomanufacturing Interagency Working Group entitled “Building a Vibrant Domestic Biomanufacturing Ecosystem.” The...more

Foley Hoag LLP - Cannabis and the Law

U.S. Virgin Islands Opens Adult-Use Cannabis License Application Process

On April 17, 2024, the Virgin Islands Cannabis Advisory Board (“VICAB”) approved regulations outlining the requirements for its new adult-use cannabis program, including details regarding the competitive merit-based...more

J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

J.S. Held on

Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

Foley & Lardner LLP

BIOSECURE Act: Anticipated Movement, Key Provisions, and Likely Impact

Foley & Lardner LLP on

Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.  The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more

Foley & Lardner LLP

Using Global Patent Trends in Smart Manufacturing to Develop an Informed and Effective IP Strategy 

Foley & Lardner LLP on

In today’s global economy, product research and development (R&D) has historically been concentrated in the U.S. and China. However, these efforts are beginning to decentralize and spread into new regions, such as Japan and...more

Bergeson & Campbell, P.C.

Mixed Algae Conversion Research Opportunity Will Award up to $18.8 Million to Address R&D Challenges in Converting Algae to...

On April 10, 2024, the U.S. Department of Energy’s Bioenergy Technologies Office (BETO) and Office of Fossil Energy and Carbon Management (FECM) announced the MACRO: Mixed Algae Conversion Research Opportunity funding...more

Wiley Rein LLP

Wiley's 10 Key Trade Developments: The CHIPS Act and Inflation Reduction Act (IRA)

Wiley Rein LLP on

These two laws usher in a new era of industrial policy, providing billions of dollars for new infrastructure, high-tech research and development, and growing and strengthening the industrial manufacturing base. ...more

Guidepost Solutions LLC

Navigating the DEA Registration Application Process

Did you know that the United States currently has over 2 million Drug Enforcement Administration (DEA) registrants engaging in activities with controlled substances? Whether you’re a student in residency, a healthcare...more

Hogan Lovells

New Commission Action Plan to boost biotechnology and biomanufacturing in the EU

Hogan Lovells on

Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic areas with ever-increasing growth...more

Holland & Knight LLP

Capturing Industrial Base from the DoD

Holland & Knight LLP on

With ever-increasing threats from the Chinese Communist Party, recently exposed vulnerabilities in the United States' supply chain and decades of outsourcing that has left the defense and industrial base vulnerable, there is...more

Perkins Coie

BARDA BioMaP-Consortium Up and Running

Perkins Coie on

In a previous Update, we reported on the Biomedical Advanced Research and Development Authority’s (BARDA) plans to implement the new Biopharmaceutical Manufacturing Preparedness-Consortium (BioMaP-Consortium or Consortium),...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Axinn, Veltrop & Harkrider LLP

HHS to Go a March-In'

Following years of discussion and pressure being applied by certain policymakers (including Senate HELP Committee Chair Bernie Sanders), the Biden Administration announced that a framework is being put forward by HHS and the...more

Woodruff Sawyer

How to Manage Exposures When Commercializing a Life Sciences Product

Woodruff Sawyer on

The road to commercializing a life sciences product is a long one, spanning years to perform research, develop the product, conduct clinical trials and testing, and receive approval from the Food and Drug Administration...more

Akin Gump Strauss Hauer & Feld LLP

Biden Administration Research and Development Executive Order May Impact University, Academic Medical Center, and Independent...

On July 28, 2023, the Biden administration issued “Executive Order on Federal Research and Development in Support of Domestic Manufacturing and United States Jobs” (the “Executive Order”). How federal agencies implement...more

Akin Gump Strauss Hauer & Feld LLP

Federally Funded Research & Development: New Executive Order Pushes Federal Agencies to Take Title to Subject Inventions and...

Key Points - On July 28, 2023, President Biden signed EO 14104, “Federal Research and Development in Support of Domestic Manufacturing and United States Jobs,” which aims to increase domestic manufacturing and...more

Pillsbury Winthrop Shaw Pittman LLP

Exploring R&D Opportunities under the CHIPS Act

The CHIPS R&D Office is advancing innovation and creating opportunities across industry. $11 billion has been appropriated to the CHIPS Research and Development Office to advance research and development of semiconductor...more

Morrison & Foerster LLP - Government...

Biden Executive Order Has Potential To Discourage U.S. Company Participation In Federal Research

A new Biden administration Executive Order proposes to enforce more rigorously U.S. manufacturing requirements attendant to federally funded inventions. While the aim of the Executive Order is to support domestic...more

Benesch

3D Printing Report - Q1-Q2 2023

Benesch on

This report explores developments in 3D printing across several sectors and categories for the half-year period of January 1, 2023–June 15, 2023. ...more

Bergeson & Campbell, P.C.

EuropaBio Offers Recommendations on Biomanufacturing

On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted...more

K2 Integrity

Post-Pandemic Era: Understanding the CHIPS and Science Act of 2022 and Its Impact on the Construction Industry

K2 Integrity on

The COVID-19 pandemic created unprecedented challenges in technology, with the demand for equipment increasing dramatically as the world quickly transitioned into remote operations. During this time, the United States’...more

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