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The law aimed at improving the framework for French health care centers has finally been published!

The French law n° 2023-378 of 19 May 2023 on the supervision of health care centers has finally been published in the Journal Officiel. The text, which has reached a consensus, was...


SCOTUS won’t hear Teva v. GSK: Where does that leave us on FDA labeling carve-outs?

The Supreme Court of the United States has denied certiorari in the Teva v. GSK “skinny labeling” case, leaving intact the Federal Circuit’s August 2021 decision, which we ...


Impacts of the U.S. IRA on licenses and collaborations

The Inflation Reduction Act of 2022 (IRA) includes a number of provisions relevant for drug pricing and reimbursement, including the Drug Price Negotiation Program (Price Negotiation...


CMS Proposes Significant Changes to Medicaid Drug Rebate Program

On May 23, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled Misclassification of Drugs, Program Administration and Program Integrity Updates...


Spotlight on Greater China: antitrust and regulatory risks in life sciences distribution channels

As part of a new Asia-Pacific (APAC) Life Sciences and Health Care webinar program designed both for companies with commercial interests in APAC and for companies based in the region, Hogan ...

Insights and Analysis

Accelerating Innovation: A New China Rule for Innovative Drug Registration Communication and Review

On March 31, 2023, the Center for Drug Evaluation under the PRC National Medical Products Administration issued the Work Specification for Accelerating the Review of Innovative Drug...


French decree regarding the “direct access”: a half-hearted step forward for pharmaceutical innovations

Publication of the French decree regarding the experimentation of the "direct access" to pharmaceutical products with anticipated reimbursement: a half-hearted step forward for...

Insights and Analysis

EU Lawmaker proposes to regulate generative AI – among other significant changes to the forthcoming AI Act
Registered Content

On Thursday, 11 May, the Committees of the European Parliament for the Internal Market and Civil Liberties voted for far-reaching amendments to the EU’s proposed artificial...


FDA issues milestone draft guidance on decentralized clinical trial design & implementation

The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and...

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