Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
In 2024, the federal government continued to shape the research compliance landscape with significant developments for research institutions across several areas. Key updates included the continued implementation of research...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
For the first time since 2009, the U.S. Department of State has proposed updates to the “Skills List” that applies to J-1 visa holders and determines, in some cases, whether the J-1 visa holder is subject to the two-year home...more
Researchers from the National Institutes of Health (NIH) have developed an algorithm that harnesses AI to help accelerate the process of matching potential volunteers for relevant clinical research trials. The algorithm,...more
On November 14, 2024, the Government Accountability Office (GAO) released its Bid Protest Annual Report to Congress for Fiscal Year 2024. The statutorily mandated report contains an array of information about GAO’s bid...more
When President-elect Donald Trump is inaugurated as the 47th president of the United States on January 20, 2025, he is expected to hit the ground running. A few months into his presidency, he will likely release the fiscal...more
President-Elect Donald Trump is poised to expand upon policies he implemented during his first term in office, such as those emphasizing limited government, states' rights and lower taxes. Additionally, it is anticipated that...more
In recent months, NIH signaled that it, in the words of Director Monica Bertagnolli, understands the “difficult climate for our valued Asian American, Asian immigrant and Asian research colleagues who may feel targeted and...more
On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we check in on ballot initiatives, or rather, lawsuits surrounding ballot initiatives. Then we see a new...more
On 12 September 2024, the Office of Research Integrity (ORI) within the US Department of Health and Human Services (HHS) issued a final rule (Final Rule) that significantly modified the standards, procedures, and requirements...more
Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
Background on Indiana’s “Baby HSR” Law - Indiana passed Senate Bill 9 in March 2024, which requires an Indiana healthcare entity involved in a merger or acquisition with another healthcare entity with a value of at least...more
As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
The U.S. Food and Drug Administration (FDA) has revoked its regulation authorizing the use of brominated vegetable oil as a food ingredient used to stabilize flavoring oils in fruit-flavored beverages after concluding it is...more
In early May 2024, the New Civil Liberties Alliance (NCLA) notified the U.S. Consumer Product Safety Commission (CPSC) that it intended to file suit against CPSC and CPSC Commissioner Richard Trumka for allegedly violating...more