Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more
The US Food and Drug Administration (FDA) is resolute in its quest to phase out its enforcement-discretion approach for laboratory-developed tests (LDTs). On October 3, 2023, FDA published a proposed rule to confirm that LDTs...more
Boston, the San Francisco Bay Area, and San Diego are once again the top markets for life sciences commercial real estate in the U.S., with plenty of opportunities for growth as biotech readies for a comeback, according to a...more
The average vacancy rate for laboratory and research and development space across the top 13 U.S. life sciences markets stood at 9% in the second quarter, up more than four percentage points from a year earlier and more than...more
California was, by January 1, 2023, home to nearly 470,000 jobs that generated $413.7 billion in total business output in 2022, according to Biocom California’s 2023 Economic Impact Report. This represents a nearly 8 percent...more
Perhaps nowhere do technology and real estate intersect more deeply than in the life sciences industry, where sophisticated technologies are integral to tenants’ operations. The life sciences industry, which was experiencing...more
The real estate needs of life sciences companies can be fluid and complex, with early stage companies typically needing smaller flexible space and later stage companies typically requiring larger build-to-suit space. With an...more
This article is the third in a multi-part series examining the impact of the COVID-19 pandemic on select real estate sectors and the considerations around how technologies will shape future operations and accelerate means to...more
Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020, the Food and Drug...more
In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more
On March 16, 2020, the US Food and Drug Administration (FDA) announced several initiatives intended to further increase access to validated COVID-19 testing. This alert addresses key components of the announcement, which...more
$3 billion recovered under the False Claims Act (“FCA”). That’s what the US Department of Justice (“DOJ”) reported collecting in FY2019. The health care and life sciences industries accounted for $2.6 billion of the total...more
This is the first installment in a series on advancements in microbiome research and development. Our goal with this series is to inform readers about developments in this important and growing field and to highlight, where...more