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Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance).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.
Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.
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.
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.
On 23 February 2022, the European Commission published its much-anticipated draft corporate sustainability and due diligence directive (the Draft Directive).
On 23 February 2022, the European Commission published its much-anticipated draft corporate sustainability and due diligence directive (the Draft Directive).
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.
Whether attorneys are drafting briefs, composing legal memos, or preparing litigation documents, the ability to convey arguments and information clearly and persuasively is essential. Lawyers need to draft meticulously documents such as contracts, wills, and statutes to ensure that these documents are enforceable and comprehensible.
Vanuatu published the first draft of the resolution in late 2022. The draft was then altered through a series of consultations with UN delegates in the following months. On March 1, 2023, Vanuatu announced overwhelming support for the draft resolution with 105 co-sponsor states. The initiative gained traction.
Furthermore, the draft plan being debated at the time contained a 23% reduction target for GHG emissions, which plaintiffs argued did not align with the long-term goals of the Paris Agreement. On March 7, 2022, the Supreme Court decided that Greenpeace v. A year after the deadline, the plan had yet to be approved. Greenpeace v.
Her expertise includes developing regulatory strategies, preparing regulatory submissions, drafting policies and procedures, and addressing enforcement matters. About the FDA’s TAP Pilot Program: CDRH introduced the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot in late 2022.
This might include, but definitely isn’t limited to: Researching or performing due diligence for a client’s matter Correspondences or meetings related to a case Drafting briefs Filing paperwork Court appearances On the other hand, a great deal of legal work falls into the non-billable hour camp.
28] Be that as it may, if His Majesty’s Government implements its ratification plan as diligently as promised, the HCCH 2019 Judgments Convention may well be the first new building block in the reconstruction what has been significantly shattered on both sides by the twists and turns of Brexit. 30] Draft Statutory Instruments 2024 No.
The EU Sustainability Directive and Jurisdiction The Draft for a Corporate Sustainable Due Diligence Directive currently contains no rules on jurisdiction. Sommerfeld ) The Proposal for a Directive on Corporate Sustainability Due Diligence The process towards an EU Corporate Sustainability Due Diligence Directive is gaining momentum.
On 23 February 2022, the European Commission published its proposal of a Directive on Corporate Sustainability Due Diligence (CSDD) in respect to human rights and the environment. This may be poor drafting, but there is apparently no material consequence arising out of it. by Rui Dias. .
It’s like a personal assistant who diligently notes every minute you spend on each case to ensure you get compensated for all your effort. in 2022), it’s the right time to look at your current rates and see if you’re charging enough to remain profitable. They capture every task you do, from drafting documents to client consultations.
Diaz Trade Law diligently worked with different CBP teams such as the Center of Excellence and Expertise (CEE), the ACE Client Representative and the Entry Team at the local port, to provide resolution to the entry in question. CBP agreed with DTL’s protest – saving our client thousands! & Chinese Companies Fined $2.5
JURIST staffers from the University of Pittsburgh School of Law are filing dispatches on various aspects of the November 2022 midterm elections in Pennsylvania. A friend of mine who works for Allegheny County and was “drafted” for election duty even told me that she met a German reporter covering the vote yesterday.
Share 2022 was a turbulent year for the Supreme Court. In May, a draft opinion by Justice Samuel Alito was leaked to the press , revealing that a majority of the court was poised to overturn the constitutional right to an abortion. In October, the court began its 2022-23 term with its lowest public approval ratings in modern history.
The sponsors of the Fashion Sustainability Act hope to bring the legislation to a final vote in the late spring of 2022. Since being introduced, most brands have yet to comment on the measure and its potential implications for their ESG due diligence efforts. Reactions to the Legislation. The Act’s Implications for ESG Compliance.
Revisions to the pending Journalism Competition and Preservation Act were released to the public this week ( revised draft bill ). The new draft makes a number of changes, including providing more details on the mechanics for forming negotiating groups of traditional media companies to qualify for the antitrust exemption.
Fish and Wildlife Service agreed to prepare a draft recovery plan for the jumping mouse by the end of January 2022, and to finalize the plan by the end of January 2023. Federal Court Directed Department of Interior to Search for Drafts of Zinke Order Rescinding Moratorium on Coal Leasing Program. Continental Resources, Inc.
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