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New Regulations Medical Devices Pharmaceutical Industry

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

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In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Hogan Lovells

New ministerial guidance letter: a vague framework that contradicts three of the CEPS's positions while leaving it alone in charge...

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The new ministerial guidance letter (‘LOM’) intended to guide the Economic Committee for Health Products (‘CEPS’) on the pricing strategy for pharmaceutical products and medical devices has been signed and published on 5 May...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

ArentFox Schiff

What Life Sciences Companies Need to Know in 2025

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Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more

A&O Shearman

New CJEU ruling on the borderline between medicinal products and medical devices: Key takeaways

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The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Second Quarter of 2025 and Beyond

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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

McDermott Will & Emery

Key Features of the New EU Product Liability Directive: Increased Potential for Litigation in the Technology, Pharmaceutical and...

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On October 10, 2024, the Council of the European Union adopted the new EU Directive on Liability for Defective Products (New PLD), repealing Directive 85/374/EEC (PLD), adopted in 1985....more

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

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On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Knobbe Martens

New Ethylene Oxide Regulations may Raise Cost of Sterilization

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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

Hogan Lovells

Medical device advertising in Spain

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The Ministry of Health takes steps to update the regulatory framework applicable to the advertising of medical devices. The Spanish Health Act gives the authorities control over health advertising. In particular, Article 102...more

Latham & Watkins LLP

UK’s MHRA Seeks “Bold New Regulatory Regime” for Medical Devices and Diagnostics

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The agency’s consultation on the post-Brexit regulatory framework for medical devices and diagnostics aims to support innovation and sustainability, among other goals. A 10-week consultation launched by the UK’s Medicines...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

McDermott Will & Emery

The EU Medical Device Regulation: What’s Next?

The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more

Hogan Lovells

Updates on the newest regulatory legislation (Royal Decree 717/2019) in Spain

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On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...more

Latham & Watkins LLP

Time to Prepare for New EU Medical Device Regime

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Companies should act now to prepare for the full implementation of the MDR and IVDR. On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...more

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