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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

As a result of reforms enacted by the Food and Drug Omnibus Reform Act of 2022 (FDORA), FDAs authority to approve as well as withdraw an accelerated approval was given new regulatory teeth to ensure that confirmatory trials are conducted expeditiously. However, the meaning of due diligence has long been a question.

Diligence 105
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Australia introduces law to prevent construction of Russian embassy near parliament building

JURIST

At a press conference , Australian Prime Minister Anthony Albanese said that the law has been expedited to prevent a formal Russian diplomatic presence near the parliament. The Australian government sought to cancel the lease following Russia’s unlawful invasion of Ukraine in 2022 and subsequent cyber security threats to Australia.

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Russia sentences over 200 Ukrainian fighters to prison

JURIST

Addressing an inquiry into the alleged crimes of Ukraine, Lavrov informed the news agency that Russian law enforcement authorities are diligently documenting the alleged “atrocities” committed by Ukrainian neo-Nazis that can be traced back to as early as 2014.

Diligence 211
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TechReport 2022: Cloud Computing

LawTechnologyToday

The 2022 ABA Legal Technology Survey Report showed the surge in cloud usage we expected after March 2020 starting to take off, led by solo lawyers. The 2022 Survey focused on cloud computing as a platform for a “web-based software service or solutions,” including Software as a Service (SaaS).

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Six Trends That Will Shape Public Safety in 2022

The Crime Report

Driven by calls to “reimagine public safety,” many public safety agencies are partnering with other government agencies and community organizations while restructuring some traditional law enforcement functions. Agencies should use the data they collected to embed a culture of diligence and innovation in the organization.

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Legal Staffing Lessons for Today’s Marketplace

Attorney at Work

Law firms didn’t let the pandemic get in the way of profitability or performance in 2020. Successful law firms not only accommodated dynamic client needs in this moment of unprecedented upheaval, but also made internal structural changes to ensure the work got done as efficiently and cost-effectively as possible.

Legal 285
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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. From an older date is a 2014 special issue of Erasmus Law Review , co-edited by Kramer and Carballo Piñeiro on the role of PIL in contemporary society.