[co-author: Julian Klein*] On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and Biologics Guidance for Industry” (the “Draft Guidance”).[1] FDA’s so-called “accelerated approval” program is designed to expedite the…
Left: President-elect Donald Trump speaks during a news conference at Mar-a-Lago, Monday, Dec. 16, 2024, in Palm Beach, Florida (AP Photo/Evan Vucci, file). Right: Enrique Tarrio and the Proud Boys demonstrate near Freedom Plaza during the Million Maga March protest regarding election results on November 14, 2020 in Washington D.C. (Chris Tuite/imageSPACE/MediaPunch /IPX). Inset: Zuny…
The US Court of Appeals for the Ninth Circuit on Friday partially revived a suit alleging improper FBI surveillance of Muslim residents of Southern California. The case was heard on remand from the United States Supreme Court and decided on the findings of the District Court. Yassir Fazaga and other plaintiffs had initially filed a…
Carnival Cruise Passenger Convicted of Multiple Charges of Sexual Abuse of Minor on Carnival Legend Cruise Ship – LexBlog Skip to content Source link
Earlier this week, the Montana Supreme Court affirmed a lower court ruling in favor of plaintiffs in a climate case based on certain provisions of the Montana constitution. Specifically, the court ruled that: The Montana Constitution’s guarantee of a “clean and healthful environment” includes a stable climate system that sustains human lives and liberties….
The Dauphin County Prison in Harrisburg, Pennsylvania, is seen in this August 15, 2019 photo. (AP Photo/Michael Rubinkam) A Pennsylvania prison is facing a class-action lawsuit filed on behalf of dozens of men who say the warden cut heat and power while they were held in solitary confinement, and deprived them of toilet paper, showers,…
Construction contracts often give one party discretion over certain aspects of the administration of a project. For example, a contract may give the owner the “sole discretion” to approve the use of contingency on a job or whether to give a contractor a time extension for an excusable delay. Even where an owner has discretion…
In the Sunday Book Review, Tom Fox considers books that interest the compliance professional, the business executive, or anyone curious. These could be books about business, compliance, history, leadership, current events, or anything else that might interest Tom. In December, Tom will review the top books in some key areas of interest for compliance professionals…
Left: Donald Trump speaks at the annual Road to Majority conference in Washington, DC, June 22, 2024 (Allison Bailey/NurPhoto via AP). Right: Fulton County District Attorney Fani Willis arrives during a hearing on the Georgia election interference case, Friday, March, 1, 2024, in Atlanta (AP Photo/Alex Slitz, Pool). The Georgia Court of Appeals on Thursday…
The Public Prosecutor’s office in Guatemala conducted an operation at the compound of Lev Tahor, an extremist Jewish sect, on Friday. Following reports of abuse within the group, the authorities performed a search and seizure, taking at least 40 women and 160 minors into protective custody. Authorities also discovered at least one skeleton of a…
