DOJ’s FCA Recoveries Were Lowest Level Since 2008 -
On February 7, 2023, the US Department of Justice (DOJ) released statistics about False Claim Act (FCA) settlements and judgments for the 2022 fiscal year. Total...more
On December 20, 2022, the US Senate unveiled the long-awaited federal omnibus spending bill. The US House of Representatives passed—and President Biden signed—the bill three days later, which will keep the federal government...more
On November 18, 2022, a collection of organizations and providers that oppose abortion filed suit against the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS), seeking — among...more
In July 2018, the Court of Justice of the European Union (ECJ), the EU’s Highest Court, issued a decision clarifying whether the EU would regulate products of innovative breeding techniques, like gene editing, under the EU’s...more
On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a...more
As critical product shortages arose during the early days of the COVID-19 pandemic, the Food and Drug Administration (FDA) issued guidance documents outlining temporary policies that allowed non-drug manufacturers to produce...more
Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that...more
With the FDA’s emergency use authorization (EUA) and now widespread availability of multiple COVID-19 vaccines in the United States, an increasing number of public and private entities are considering requiring or have...more