Alerts

The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy.

The World Bank’s International Centre for Settlement of Investment Disputes (ICSID), the leading arbitration venue for investor-State arbitration, has released its FY2020 caseload statistics.

Headlines that Matter for Companies and Executives in Regulated Industries

On October 1, 2020, the US Department of Treasury’s Office of Foreign Assets Control (OFAC) issued an Advisory highlighting sanctions risks associated with facilitating ransomware payments on behalf of victims targeted by malicious cyber attacks.

SPAC transactions present an opportunity for accelerated growth in the AgTech industry, especially in capital-intensive businesses.

As we navigate life in the era of the global pandemic and the ever-changing risk assessments for contracting the novel coronavirus, one thing is becoming clear: face masks are here to stay for the foreseeable future.

With increased financial pressure on the health care delivery system, there is likely to be an increase in health care provider financial restructurings.

Now is the time to review your internal contracts, procedures, marketing materials, and policies and prepare your company to capitalize on the next opportunity.

On September 24, 2020, the California Court of Appeal shed additional light on meeting the public interest requirements in anti-SLAPP motions in its opinion of Murray v. Tran (Cal. Ct. App., Sept. 24, 2020, No. D076104).

For several weeks, parties to pending merger and sale transactions involving Paycheck Protection Program (PPP) loans have been asking what will happen to PPP loan forgiveness applications if a borrower sells its business prior to receiving confirmation of forgiveness; a process that has barely start

California Governor Newsom signed Senate Bill 1237 (SB 1237), broadening the certified nurse midwife (CNM) scope of practice, among other changes to the Nursing Practice Act and other Sections of the Business and Professions Code. 

The California Consumer Privacy Act (CCPA), the landmark privacy law making waves since taking effect earlier this year, has continued to evolve as legislators and the California Office of the Attorney General refine and clarify its requirements.

For the first time, California has granted nurse practitioners who meet certain qualifications a separate scope of practice. This eventually will allow them to practice specified medical functions independently, without standardized procedures.

Headlines that Matter for Companies and Executives in Regulated Industries

US authorities announced that they reached an agreement with JPMorgan Chase & Co. (JPMorgan Chase) to settle criminal charges related to two distinct years-long market manipulation schemes involving hundreds of thousands of spoof orders on precious metals and US Treasury futures contracts. 

Senior debt holders who are entitled to be paid ahead of contractually subordinated creditors pursuant to a subordination agreement now need to closely review and scrutinize their treatment under a proposed chapter 11 plan.

The October, 2020 Visa Bulletin significantly advanced the availability of green cards for most categories, allowing thousands of foreign nationals to file their last step in the green card process.

Government contractors may wish to seek further legal review of all diversity and inclusion training materials used.

The US Environmental Protection Agency has proposed to amend its pesticide regulations to exempt from FIFRA, the federal pesticide statute, certain pesticidal substances (PIPs) created in plants using biotechnology.

This post explains steps that Illinois LLCs and their majority members can take to protect otherwise privileged communications from disclosure to minority members in advance of and during litigation.

Effective January 1, 2021, California employers must provide significantly expanded family and medical leave under state law. 

Substantial funding for precision agriculture is anticipated as part of FCC 5G Fund to support next generation wireless services.

On September 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it streamlined the federal Clinical Laboratory Improvement Amendments (CLIA) certification process for laboratories applying to perform COVID-19 testing.

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.