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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...


FDA issues milestone draft guidance on decentralized clinical trial design & implementation

The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and...

Insights and Analysis

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

In this Q2/23 issue of our Life Sciences and Health Care Law Update, our teams highlight key developments across life sciences regulatory, compliance, competition, and privacy throughout...


After the Public Health Emergency: FDA plans to revise COVID-19 EUA policies

On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will...


French CNIL is setting the tone for 2023: patients data and medical research on its radar

While the French Data Protection Authority (the "CNIL") has consistently emphasized the importance of protecting health data, there will be even more focus for 2023 with more...


CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction...


The False Claims Act Guide: 2022 and the road ahead

In the latest edition of our False Claims Act Guide: 2022 and the road ahead, we analyze the key developments from 2022 and discuss how the most important cases and issues are shaping FCA...

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