On December 29, 2022, President Biden signed into law the “Modernization of Cosmetic Regulation Act of 2022,”1 which requires increased Food and Drug Administration (FDA) oversight of cosmetics and the ingredients in them.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) creates federal standards for cosmetic products registration, product listing, good manufacturing practice, recordkeeping, recalls, adverse event reporting and safety substantiation.
On Oct. 31, 2022, Valisure LLC submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) requesting, inter alia, a recall of dry shampoo products containing benzene.
Clinical trial fraud has come under the microscope at two of the largest federal overseers – and life sciences companies need to take notice.
In its first occasion to interpret § 353b of the Federal Food, Drug, and Cosmetic Act (FDCA), the US Court of Appeals for the Ninth Circuit relied on the “implied preemption doctrine” to affirm a district court’s case dismissal for failure to state a claim under Fed. R. Civ. P. 12(b)(6).
Commissioner of Food and Drugs Dr. Robert Califf has raised at least two major issues that he hopes to address in his current tenure.
The US Court of Appeals for the Federal Circuit affirmed a district court’s finding of noninfringement in a Hatch-Waxman case under 35 U.S.C. § 271(e)(2) and § 271(a)-(b).
The Chinese government's past efforts to reform its pharmaceutical industry's regulatory framework can be traced back to the 2015 Opinions on the Reform of Evaluation and Approval System for Drugs and Medical Devices (2015 Opinions) and 2017 Opinions on Deepening the Reform of the Evaluation and Approval System and Inspiring Innovation of Drugs and Medical Devices.
For a number of reasons, general regulatory enforcement in the life sciences industry took a back seat throughout much of 2020 and 2021. While there were differing approaches depending on which administration was in control of the White House, much of the focus in life sciences enforcement was squarely on the COVID-19 pandemic. And while that is still the case in some respects, priorities are beginning to shift, and the industry needs to take notice.
On June 6, the Supreme Court in Gallardo v. Marstiller resolved an ambiguity in the Medicaid statute that could have significant ramifications for those seeking to settle personal injury cases involving a plaintiff who is on Medicaid. The case focused on a provision in the Medicaid Act requiring states to compel Medicaid beneficiaries to assign their rights “to payment for medical care from any third party[.]”
On December 16, 2022, a federal district judge in California denied artist Ryder Ripps’s and his partner’s anti-SLAPP motion and motion to dismiss in a closely monitored action filed against them by Yuga Labs, Inc. (“Yuga”), the creator behind the monumentally successful Bored Ape Yacht Club (“BAYC”) NFTs.
If your New Year’s resolution is fitness-related, we’re on the same page … or hamster wheel.
Even with the strictest compliance with Occupational Safety and Health Administration (OSHA) regulations and best workplace safety practices, on-the-job injuries from time to time are inevitable in the construction industry.
The Equal Employment Opportunity Commission (EEOC) promised in a March 2022 hearing to address what it considered to be “severe and pervasive” discrimination in the construction sector.
On December 2, 2022, President Joseph Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (Cannabis Research Act), which provides a mechanism for industry and academia to access and research cannabis, including marijuana and other cannabis-derived products without violating the Controlled Substances Act (CSA).
Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules governing prescription drug data collection (RxDC).
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