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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

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. However, it left unanswered what underway means, noting an intention to address this authority in the now published January 2025 draft guidance.

Diligence 105
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Graduation Virtual Live Stream - February 22, 2025

Paralegal.edu

On Saturday, February 22, 2025, at 10:00 AM Central, Center for Advanced Legal Studies (CALS) will hold its 75th Commencement Ceremony for graduates of its paralegal programs. She manages all aspects of diligence and the FCPA compliance program. The commencement address will be presented by Elisa Calderon-Sierra, CFE.

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The Alert: April – June 2025

Parasec

As of March 21, 2025, U.S. For non-exempt foreign companies, new deadlines are in place: Entities registered before the interim final rule (published on March 21, 2025) must file BOI reports within 30 days. companies and individuals are no longer required to submit beneficial ownership information (BOI) to FinCEN.

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Human rights groups urge EU to reject proposed Omnibus Directive

JURIST

The proposal , introduced by the European Commission in February 2025, aims to streamline corporate sustainability reporting and due diligence requirements. The proposal is part of a broader effort to reduce regulatory burdens on businesses and enhance the EU’s global competitiveness.

Diligence 104
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The New Way of Conducting Patent Research: Proven Strategies For Efficient Due Diligence

Speaker: Andrew Klein and Jennifer Vandenplas

Patent due diligence processes take too long. Join us to hear best practices in researching and producing thorough patent due diligence reports. Register now and start mastering patent due diligence like a pro! There are better methods!

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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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Authorities urged to safeguard human rights and civil society ahead of EU-Central Asia Summit

JURIST

The summit will be held on April 3 and 4, 2025, in Samarkand, Uzbekistan. On Monday, Amnesty International urged Central Asia and EU nations to focus on actively protecting human rights and civil society spaces during the upcoming EU-Central Asia Summit.

Diligence 104