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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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Human Rights Watch accuses sponsors of China Winter Olympics of supporting Uyghur genocide

JURIST

Human Rights Watch wrote letters to sponsors, asking the sponsors to confirm whether they had “conducted human rights due diligence for the 2022 Beijing Olympics” and to explain what work was done to ensure the supply chain does not “contribute to human rights violations.”.

Diligence 232
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Ohio top court dismisses challenges to congressional maps

JURIST

Both suits were filed shortly after the Ohio Redistricting Commission approved Republican-created congressional maps on March 2, 2022. After nearly two years of diligently pursuing this litigation, Petitioners have decided that it is not presently in the state’s best interests to continue pursuing relief in this manner.

Court 223
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Six Trends That Will Shape Public Safety in 2022

The Crime Report

Agencies should use the data they collected to embed a culture of diligence and innovation in the organization. Regardless of the approach each agency ultimately takes, any public safety strategy will have to grapple with six key trends that are likely to dominate the conversation in 2022. In 2022, these calls will get more insistent.

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Thailand court’s dismissal of spyware misuse lawsuit spurs international concern

JURIST

Pai first brought the tort complaint in July 2023 based on a warning email sent by Apple and a 2022 joint report by Thai civil society groups and Citizen Lab. The report found that the Pegasus spyware attacked at least 30 people, most of whom were involved in the 2020-2021 protests for Thailand’s Pro-Democracy Movement.

Diligence 104
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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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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