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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study.

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EU faces criticism for rollback on corporate human rights and environmental obligations

JURIST

The Corporate Sustainability Due Diligence Directive (CSDDD), which came into force in 2024 as part of the European Green Deal , aims to protect human rights and the environment across corporate supply chains. The human rights organization warned that this would allow companies to ignore high-risk areas of their supply chains.

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Extension of deadline (to 10 January 2025) for Call for Papers for Special Issue of the Journal of Sustainable Development and Policy on the theme, “Private International Law and Sustainable Development in Africa”

Conflict of Laws

by 10 January, 2025 with the email subject clearly marked Submission Proposal Special Issue JSDP PIL and Sustainable Development in Africa. Proposals will be reviewed by the editors and selected participants will be informed by the end of January 2025.

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Time’s Up: Will Law Firms Say Goodbye To Billable Hour In The (Gen)AI Era?

Above The Law

In our forthcoming Spring 2025 publication, Fighting the Hypothetical: Why Law Firms Should Rethink the Billable Hour in the Generative AI Era, [1] we hypothesize that Generative AI (GenAI) technology will change forever how legal services are delivered and will force law firms to re-engineer their legacy economic model.

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Ethics Meets Opportunity – How AI Can Propel Your Paralegal Career

Paralegal Bootcamp

So youre really good at drafting discovery, doing legal research, managing document productions, etc. Maybe not right away in 2025, but I think well definitely start seeing that competitive disadvantage by 2026 and beyond. Back then, it meant things like eDiscovery and trial technology, or online due diligence software tools.

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Call for Papers for Special Issue of the Journal of Sustainable Development and Policy on the theme, “Private International Law and Sustainable Development in Africa”

Conflict of Laws

Proposals will be reviewed by the editors and selected participants will be informed by the end of January 2025.

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Law Firm Management in 2025: Achieving Total Control Over Your Practice

CosmoLex

Examples include scheduling and attending appointments and meetings, maintaining client relationships, and completing your day-to-day legal tasks, such as performing due diligence, drafting contracts, preparing for trial, and other billable hour tasks. As a result, its critical to keep your documents organized and secure.