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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Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). That post largely focused on endpoints as well as the broader context for when accelerated approval is appropriate. Tobolowsky & Charles G. Raver & James E.

Diligence 105
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Data Visualization Accelerates eDiscovery: Picture This

Attorney at Work

The post Data Visualization Accelerates eDiscovery: Picture This appeared first on Articles, Tips and Tech for Law Firms and Lawyers. Data visualization is gaining traction as we grapple with terabytes of electronically stored information.

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Report warns humanitarian aid urgently needed as acute malnutrition accelerates for children in Yemen

JURIST

An acceleration of acute malnutrition has made famine a real possibility in some Yemeni government-controlled areas, a report by the Integrated Food Security Phase Classification (IPC) warned on Sunday. Earlier in June, Houthi authorities raided the homes and offices of various UN and NGOs, resulting in the detainment of staff.

Education 195
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Shell settles lawsuit with Greenpeace over vessel boarding incident

JURIST

Greenpeace, known for its advocacy against fossil fuel dependency and its calls for accelerated climate action, used the protest to draw attention to Shells role in global carbon emissions. The group argued that such actions are vital to raising awareness about the environmental consequences of oil and gas production.

Legal 197
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Generative AI for Contracts Is Here: New Tools to Accelerate Drafting and Editing

In this demonstration, you'll learn how to: Generate AI-suggested redlines to accelerate in-flight agreements Prompt Evisort to draft contract language from scratch Stay in control of your data privacy while benefiting from the latest AI innovations

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France’s Council of State orders government to accelerate Paris Agreement climate commitments

JURIST

The French Council of State ( Conseil d’Etat ) ordered the country’s federal government to take accelerated action against climate change on Thursday, threatening possible fines for noncompliance. In November, the Council gave the government three months to develop a plan “that the reduction path by 2030 can be respected.”

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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 application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s.