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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).

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Draft version of redesigned bar exam will be shared by NCBE soon

ABA Journal

With a target implementation year of 2026 for a redesigned bar exam, the National Conference of Bar Examiners expects to start pilot testing this year.…

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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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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

Proposals will be reviewed by the editors and selected participants will be informed by the end of January 2025. ABOUT THE PROJECT Read more about the project The Private Side of Transforming our World UN Sustainable Development Goals 2030 and the Role of Private International Law here

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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. You jump in there and tell ChatGPT that you need help drafting a motion to dismiss on X issue.

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Iran removed from UN commission on women

JURIST

Iran was to serve its term from 2022-2026. In early November, the US promised to introduce a draft resolution in response to the government of Iran acting to “increasingly suppress the human rights of women and girls.” ” Russia requested a legal opinion on the draft resolution.

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Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog

With the current lapse in authorization, FDA may only award RPD PRVs for applications that have received an RPD designation before December 20, 2024, andunless reauthorized before thenmay not award any RPD PRVs after September 30, 2026. Below, we discuss some of its downstream impacts on the PRV landscape.