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Environmental Protection Agency (EPA) Life Sciences

Carlton Fields

Regulatory Relief to Promote Domestic Production of Critical Medicines

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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

Bergeson & Campbell, P.C.

President Trump Revokes 2022 EO on Advancing Biotechnology and Biomanufacturing

On March 14, 2025, President Trump signed Executive Order (EO) 14236, rescinding 19 executive actions, including former President Biden’s September 2022 EO 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a...more

Hogan Lovells

PRODUCT | Products Law Year in Review: Key Developments from 2024 and Future Impacts for 2025

Hogan Lovells on

2024 was a transformative year for the products law landscape, marked by sweeping regulatory shifts, emerging trends, and heightened compliance challenges. These developments are reshaping industries worldwide and will...more

Faegre Drinker Biddle & Reath LLP

Biopharma & Medical Device Briefing: PFAS Reporting Requirements; ECHA Substances of Very High Concern List; and MicroRNA...

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Morrison & Foerster LLP

Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework

Earlier this year, Uruguay announced two major updates in the patent and regulatory spheres that are likely to encourage outside investment in Uruguayan industry, particularly for agbiotech: Uruguay is acceding to the Patent...more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Knobbe Martens

New Ethylene Oxide Regulations may Raise Cost of Sterilization

Knobbe Martens on

Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to...more

MoFo Life Sciences

New Regulations Rooted In Evidence: Looking Back On How EPA And USDA Updated Engineered Plant Regulations And Labeling In 2023

MoFo Life Sciences on

Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year....more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Medical Device Developments in 2023

A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more

Morgan Lewis - Well Done

Anti-Spoil(er) Alert: FDA Issues Guidance on Antimicrobial Agents in Food

Morgan Lewis - Well Done on

FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance...more

Wiley Rein LLP

Groundbreaking Releases of Genetically Engineered Mosquitoes Hold Enormous Promise for Public Health Worldwide

Wiley Rein LLP on

Dengue Fever, Chikungunya, Zika, Yellow Fever – what do all these diseases have in common? They are caused by viruses that enter human bloodstreams via mosquito bites. The culprit that transmits these viruses is the Aedes...more

Hogan Lovells

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

Hogan Lovells on

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

King & Spalding

Emerging Regulation, Enforcement, and Litigation Involving Ethylene Oxide, a Critical Substance for Sterilizing Medical Products...

King & Spalding on

Ethylene oxide (“EtO”), one of the most widely used and effective substances for sterilizing medical products and devices, has come under intense scrutiny by the Environmental Protection Agency (“EPA”), the Food and Drug...more

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