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FDA sheds light on benefit-risk assessments to inform decision-making throughout product lifecycle

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer...

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NLRB General Counsel seeks to further shake up college sports

Earlier this month, the General Counsel of the National Labor Relations Board issued a memorandum declaring that private college athletes should be considered “employees” under...

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The Arrium Proceedings: when is a company insolvent? When is a representation not a representation?

The Supreme Court of New South Wales has recently handed down its decision in proceedings (“Arrium Proceedings”) brought by a number of lenders against former officers and...

Insights

Global ESG in Real Estate: Green Leases Webinar
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If you are wondering what green leases clauses are and how different jurisdictions are incorporating them into their real estate leases, watch the recording of our global webinar that took...

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ESG Global Vision: An interactive global guide to ESG-related laws and regulations

ESG Global Vision is your interactive guide to laws and regulations on issues related to environmental, social, and governance issues worldwide.

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Hybrid products and registration in the generics register ("répertoire des groupes génériques")

The French supreme administrative Court ("Conseil d'Etat") confirms that only the marketing authorisation may define a pharmaceutical product as generic.

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Dutch Court grants cross-border injunction in absence of a Dutch patent
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On 1 October 2021, the Provisions Judge of the District Court of Rotterdam granted a cross-border injunction in preliminary proceedings against the Dutch warehousing and distribution entity ...

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Introduction to pensions legislation for trustees
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There are two levels of legislation: primary legislation: high level statutes called "Acts", which are passed by both Houses of Parliament; secondary legislation: created...

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