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This practice note discusses FDA clinical hold orders issued to IND sponsors and covers grounds for issuing a clinical hold order, how the FDA issues an order, and how a sponsor should respond to a clinical...
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Several cases are percolating in 2022 that spotlight ERISA. Among them, Hughes v. Northwestern University, on which SCOTUS heard oral arguments in early December, and which focuses light on the pleading standards required to challenge retirement savings plans. See Oral arguments transcript. SCOTUS also has been asked to review Howard Jarvis Taxpayers Association v. California Secure Choice Retirement Savings Program. That program, already representing 11,000 employers and having combined assets over $85M, requires a portion of California workers' earnings to be automatically deposited into IRAs, where the employer does not otherwise maintain a retirement savings program for those workers. And in Belknap v. Partners Healthcare System, Inc., a Massachusetts district court will consider a challenge to the mortality tables that the defined benefit plan of a large Massachusetts healthcare employer has relied on in calculating annuity payments, or their actuarial equivalents. Will reasonableness matter?
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