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Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a violation of the Food, Drug, and Cosmetic Act (FDCA).
Last month, in Pharmaceutical Care Management Association v. Tufte et al. No. 18-2926 (8th Cir. August 7, 2020), the United States Court of Appeals for the Eighth Circuit invalidated legislation in North Dakota on the grounds that it was preempted by ERISA.
BMW and two of its subsidiaries will pay $18 million to end allegations from the U.S. Securities and Exchange Commission that the carmaker inflated its reported retail sales in the U.S. through misleading disclosures, the agency announced.
Headlines that Matter for Companies and Executives in Regulated Industries
Schiff Hardin LLP is pleased to announce that the firm’s Intellectual Property Practice Group has received the Impact Case of the Year award in 2020 by LMG Life Sciences for our ground-breaking patent-infringement victory in Fresenius Kabi v. Hospira.
As we previously reported, Maryland has passed several employment laws that go into effect on October 1, 2020.
This article was originally published in The Banking Law Journal.
HHS has finalized the CARES Act provider reporting and recoupment rules and they are different from those put forth in the proposed form. Providers should take careful note — the new requirements are significant and detailed.
In a decision with potentially far-reaching consequences for class actions, a divided panel of the U.S. Court of Appeals for the Eleventh Circuit held that the ubiquitous practice of awarding a class representative an “incentive” payment as part of a class action settlement is impermissible.
Schiff Hardin LLP is advising Consolidated Communications Holdings, Inc., a leading broadband and business communications provider, in a proposed $425 million investment agreement with an affiliate of Searchlight Capital Partners, L.P.
California is going all-in on electric vehicles.
Yesterday, the US Department of Labor’s Wage and Hour Division proposed a new rule designed to “bring clarity and consistency to the determination of who’s an independent contractor under the Fair Labor Standards Act.”
On September 18, 2020, under the authority of the Center for Medicare and Medicaid Innovation, CMS finalized the new Radiation Oncology Alternative Payment Model (Model), with a new payment methodology for radiation therapy (RT) services.
In recent years, the US health care system has experienced unprecedented challenges, an increasing pace of change, and ever-growing complexity.
SB 1159 expands the presumption of workers’ compensation liability for employees who contract COVID-19 due to a workplace outbreak.
Health Care Partner Anne Murphy will moderate a panel discussion on the state of behavioral health care in an upcoming webinar hosted by the Boston Bar Association.
Following up on the recent New York State Executive Order the New York City Department of Health and Mental Hygiene issued an alert advising providers that all point-of-care COVID-19 test results must be reported electronically via the New York State Electronic Clinical Laboratory Reporting.
Adding to various paid sick leave requirements that employers must navigate in the COVID-19 environment, California has once again expanded its state law paid sick leave mandates.
Schiff Hardin LLP is pleased to announce that three attorneys have been named to the Michigan Super Lawyers and Rising Stars lists for 2020.
Headlines that Matter for Companies and Executives in Regulated Industries
Health Care Partner Stephanie Trunk will participate in an External Counsel Fireside Chat at Informa Connect’s virtual Medicaid Drug Rebate Program on Friday, September 18, 2020. She will also host an in-depth on-demand session on reimbursement and contract strategy.
On September 14, 2020, the Department of Homeland Security (DHS) through Customs and Border Protection (CBP) issued new withhold release orders (WRO) aimed at entities involved in the importation, downstream manufacturing, and/or sale of certain apparel, cotton, hair products, and computer parts.
The Centers for Medicare and Medicaid Services (CMS) has withdrawn its proposed Medicaid Fiscal Accountability Regulation (MFAR), according to a September 14, 2020, announcement via Twitter by Administrator Seema Verma.
California Debt and Investment Advisory Commission