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Q3/2024 Life Science Law Update – Key developments for pharma & device companies in EU

The Q1 and Q3 Life Science and Health Care Law Update covers key trends in the EU only while the other reports (on Q2 and Q4) cover key trends in the EU as well as in the Big Five (France,...

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Publicly Traded Life Sciences Companies and Artificial Intelligence: Disclosing Risk Factors

Although the rise of artificial intelligence (AI) has created many opportunities and breakthroughs for life sciences companies in preclinical and clinical development, risks associated with ...

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Legislation introduced to strengthen UK post-market surveillance requirements for medical devices

A draft Statutory Instrument was laid before UK Parliament on 22 October 2024 which, once passed, will introduce new post-market surveillance (PMS) requirements for medical devices and in...

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Regulation for medicines manufactured at the point of care introduced before UK Parliament

The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients ...

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Safe and correct use of food in interventional human studies

In the Netherlands, the Central Committee on Research Involving Human Subjects (CCMO) recently published a guideline to clarify the requirements applicable to interventional studies...

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Final FDA electronic systems guidance offers greater compliance flexibility

The U.S. Food and Drug Administration (FDA) finalized its revised guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical...

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CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program...

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CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program...

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Ninth Circuit strengthens FDA authority to enforce drug regs against certain stem cell products

The U.S. Court of Appeals for the Ninth Circuit on Friday reversed the district court’s judgment in United States v. California Stem Cell Treatment Center, siding with the U.S. Food...

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