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France Adopts a Law Banning PFAS in Cosmetics, Textiles, and Waxing Products

After several months of uncertainty due to amendments made by the Senate and the dissolution of the National Assembly shortly thereafter, France finally passed a law on February 27, 2025, aiming to reduce risks associated...more

EUROPE – New Interim Guidance on Parallel EMA-HTA Body Scientific Advice

On July 3, 2023, the European Medicines Agency (“EMA”) and the European Commission published a Guidance on Parallel EMA/HTA body Scientific Advice for the Interim Period (“Guideline”). The Guideline organizes parallel...more

With Risk Comes Responsibility: EU Proposes High-Risk AI Regulation Affecting Device Manufacturers

In April 2021, the European Commission proposed the EU Artificial Intelligence Act, a first-of-its-kind regulation by any global regulatory authority. The proposed Act is intended to establish harmonized rules on artificial...more

Europe - The Proposal on “Substances of Human Origin Intended for Human Application” (SoHO Regulation) and Its Impact on Advanced...

On July 14, 2022, the European Commission (“EU Commission”) published a proposal to adopt an EU-wide Regulation on standards of quality and safety for substances of human origin intended for human application...more

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