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Webcasts November 7, 2024

Webcast: False Claims Act Enforcement in the Life Sciences and Health Care Sectors

The False Claims Act (FCA) is one of the most powerful tools in the government’s arsenal to combat fraud, waste, and abuse involving government funds—particularly federal health care program expenditures.

Client Alert November 7, 2024

False Claims Act Implications of CMS’s Final Medicare Overpayment Rule

The Final Rule brings the standard for determining when a person has “identified” an overpayment in line with the FCA’s knowledge standard and formalizes a six-month good-faith investigation period—but risks for providers remain.

Webcasts October 1, 2024

Webcast: DOJ’s Consumer Protection Branch

In this webcast, Gibson Dunn attorneys discuss how the U.S. Department of Justice’s Consumer Protection Branch has quickly become a leading criminal and civil enforcer of health, safety, fraud, and privacy laws.

Client Alert July 30, 2024

False Claims Act 2024 Mid-Year Update

This update summarizes recent enforcement activity, provides an overview of notable legislative and policy developments at the federal and state levels, and analyzes significant court decisions from the first half of the year.

Client Alert July 16, 2024

FDA Issues Overdue Guidance on Diversity Action Plans in Drug and Device Clinical Trials – What You Need to Know

On June 26, 2024, FDA released its long-awaited draft guidance on Diversity Action Plans to increase enrollment of underrepresented populations in clinical trials of drugs and devices.

Client Alert May 10, 2024

Federal Circuit Update (April 2024)

This edition of Gibson Dunn’s Federal Circuit Update for April 2024 summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning patent eligibility under 35 U.S.C. § 101, obviousness, and unenforceability due to inequitable conduct and unclean hands.

Client Alert May 8, 2024

FDA’s Final Rule on Laboratory-Developed Tests: Four Key Takeaways

The U.S. Food and Drug Administration's highly anticipated final rule on laboratory-developed tests was officially published in the Federal Register on Monday, May 6, 2024.

Client Alert April 5, 2024

Federal Circuit Update (March 2024)

This edition of Gibson Dunn’s Federal Circuit Update for March 2024 summarizes the current status of several petitions pending before the Supreme Court, and recent Federal Circuit decisions concerning indefiniteness, obviousness, eligibility under Section 101, and the safe harbor provision under Section 271.