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Insights and Analysis

European Parliament Elections 2024: Explainer and Policy Takeaways

As the EU gears up for its upcoming elections, stakeholders across sectors are closely monitoring potential shifts in policy and governance. With an anticipated right-ward shift of the...

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FDA Platform Technology Designation Program aims to speed development of drugs, biological products

The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, ...

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EMA revised its guidance on medical devices/ IVDs used in combination with medicinal products

On 21 May 2024, the European Medicines Agency (“EMA”) published a revised version of the Questions & Answers for applicants, Marketing Authorisation Holders of medicinal...

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FDA increasing efforts to support CTGT product development

FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in the...

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U.S. BIOSECURE Act: Key legal considerations for biotechnology companies

Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese...

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State laws governing abortion raise questions over legality of embryonic stem cell research

New, or newly interpreted, state laws and court decisions governing abortion may directly affect access to medical care and treatment for patients who are, or who want to become, pregnant....

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China update: Human Genetic Resources Administration Rules support HGR Implementing Rules

After years of waiting, China’s Ministry of Science and Technology (MOST) finally released the final version of the Implementing Rules on the Human Genetic Resources Administration...

Insights and Analysis

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

The Q1/24 Life Science and Health Care Law Update covers key trends across EU life sciences regulatory, corporate, compliance, competition, and privacy.Key new developments: Pharma: EC ...

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CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program...

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