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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 Blog

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance).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.

Diligence 105
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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.

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The Corporate Sustainability Due Diligence Directive: PIL and Litigation Aspects

Conflict of Laws

Introduction After extensive negotiations, on 24 April 2024, the European Parliament approved the Corporate Sustainability Due Diligence Directive (CSDDD or CS3D) as part of the EU Green Deal. A similar provision to that effect can be found in the draft UN Legally Binding Instrument on business and human rights.

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GEDIP’s Reccommendation on the Proposal for a Directive on Corporate Sustainability Due Diligence

Conflict of Laws

As reported in this blog before (see CSDD and PIL: Some Remarks on the Directive Proposal ), the European Commission on 23 February 2022 adopted a proposal for a Directive on corporate sustainability due diligence. The text of the Recommendation can be found here.

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United States: Human Rights And The Environment – What US-based Companies Need To Know About The EU Draft Corporate Sustainability Due Diligence Directive - Mayer Brown

Mondaq

On 23 February 2022, the European Commission published its much-anticipated draft corporate sustainability and due diligence directive (the Draft Directive).

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Worldwide: 日本企業が検討すべきEUコーポレート・サステナビリティ・デューディリジェンス指令案の人権と環境保護の課題について/Human Rights And The Environment – What Japanese Companies Need To Know About The EU Draft Corporate Sustainability Due Diligence Directive - Mayer Brown

Mondaq

On 23 February 2022, the European Commission published its much-anticipated draft corporate sustainability and due diligence directive (the Draft Directive).

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Transitioning to Litigation from Another Practice Area

Paralegal Bootcamp

Enrollment opens on June 7, 2022 for our next session! You haven’t done much legal research in your commercial paralegal position, but you have done some big due diligence projects on those pending transactions. L EARN MORE. Review the Job Description. With a little bit of training, that skill would be transferrable.