4,681 results found

In July, we reported that the European Medicines Agency and the US Food and Drug Administration had announced a joint proposal to promote the use of innovative approaches to paediatric drug development.

On October 19, 2020, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health released a draft discussion paper titled...

On March 13, 2023, just a week after announcing the creation of the Opioid Epidemic Civil Litigation Task Force, the Department of Justice intervened in an FCA suit in the Northern District...

In February, a federal jury in Minnesota found that Precision Lens and its co-founder, Paul Ehlen (together, Defendants), violated the False Claims Act (FCA) by submitting over 64,500...

During the second webinar in our series on "Addressing Challenges and Mitigating Risks During the COVID-19 Pandemic and Beyond," our panel covered the following topics: ◾the effects of insurance loss / economic disruption...

In June 2023, FCA practitioners around the country became familiar with U.S. ex rel. Schutte v. SuperValu Inc., when the Supreme Court issued its opinion in that case. As Qui Notes readers will recall...

On December 3, 2024, the U.S. Department of Health and Human Services Office for Civil Rights announced a $1.19 million civil monetary penalty against a Florida-based pain management clinic for alleged violations of the HIPAA Security Rule.

On October 19, the House Ways and Means Oversight Subcommittee (Subcommittee on Oversight) held a hearing on "Investigating Pandemic Fraud: Preventing History from Repeating Itself."

Earlier this summer, the Eighth Circuit was the latest circuit to weigh in on the growing split regarding what precisely a relator must plead to satisfy Rule 9(b)'s

Publication of clinical trial data and results continues to be a hot topic in the EU.

As usual, the Q3 numbers were driven mainly by a handful of large recoveries—mostly from the pharmaceutical industry.

On January 1, 2020, Congress voted to override the president's veto of the National Defense Authorization Act for Fiscal Year 2021 (NDAA), enacting the most significant overhaul of the...

On June 7, 2021, under the terms of a plea agreement, Judge Louise Flanagan of the US District Court for the Eastern District of North Carolina ordered Contech Engineered Solutions LLC (Contech) to pay...

Mr. Elwood said: "Allon is one of the most talented Supreme Court advocates in the country.

Over the weekend, Governor Newsom signed California's first in the nation greenhouse gas (GHG) emissions disclosure and climate-related financial risk reporting legislation...

There's only six months until Election Day, but we can't write off 2024 as just another "election year." Our policy analysts with decades of Hill experience discuss how the seeds...

In the latest episode of Bona Fide Needs, Pub K Managing Editor Bill Olver is joined by Arnold & Porter False Claims Act Investigations & Defense attorneys Christian Sheehan...

This time, we've reached the home stretch in our review of Justice Theis' tenure. In this post, we're reviewing the areas of law in which she's written civil majority and civil dissents.