Our FDA team published a LawFlash on the Food and Drug Administration’s (FDA’s) recent Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits.
Legal Insights and Perspectives for the Healthcare Industry
On December 8, 2020, Judge Gerald Pappert in the US District Court for the Eastern District of Pennsylvania denied a request from the Federal Trade Commission (FTC) and Pennsylvania attorney general (AG) to preliminarily enjoin a proposed merger between Thomas Jefferson University (TJU) and Albert Einstein Healthcare Network (Einstein). The case was widely watched as the FTC sought to show that the combination of these two urban hospital systems would harm consumers.
Our tax team published a LawFlash on the recently released Internal Revenue Service Revenue Ruling 2020-27 and Revenue Procedure 2020-51, which provide guidance on the deductibility of certain expenses paid or incurred in a taxpayer’s business using loan proceeds from a “covered loan” provided under the CARES Act’s Paycheck Protection Program (PPP).
Our immigration team recently posted a LawFlash to discuss a recent decision by the US District Court for the Northern District of California that set aside two Interim Final Rules (IFRs) that sought to restrict severely eligibility for the H-1B Specialty Occupation nonimmigrant category.
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential.
We invite you to join us for a webinar series where we discuss our views on the enforcement priorities expected from the incoming Biden-Harris administration.
HHS recently announced the forthcoming termination of FDA’s Unapproved Drugs Initiative (UDI), in an apparent effort to combat prescription drug shortages and price spikes.
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination.
The upcoming change in the US presidential administration is expected to significantly alter the landscape of immigration adjudication and enforcement in the United States. Our immigration team will present a one-hour webinar examining some of the changes that President-elect Joseph Biden’s administration could make to US business immigration policy, as well as recent USCIS and DOL regulatory changes and immigration in post-Brexit Europe.
Join Morgan Lewis for the first session of a new webinar series, the Morgan Lewis Global Sponsor Forum. We will discuss potential implications of the 2020 US election results across various private fund targeted industries, including healthcare and life sciences, energy and infrastructure, credit, technology, and education. This new webinar series will examine key trends, terms, and issues across these various industry sectors.