The mission of the U.S. Securities and Exchange Commission (SEC) is to protect investors, maintain fair orderly, and efficient markets, and facilitate capital formation, and the SEC&'s reach can be...

On May 9, 2022, the CFPB released an advisory opinion in which it reiterated its position that the ECOA and its implementing Regulation B protect "applicants" throughout the lifecycle of an extension of credit, and not simply during ...

On January 8, 2021, the Department of Justice (DOJ) and Securities Exchange Commission (SEC) announced that Deutsche Bank would pay more than $130 million to resolve investigations into...

On June 6, 2025, the U.S. Department of the Treasury's Financial Crimes Enforcement Network (FinCEN) issued an advisory (the Advisory) to assist U.S. financial institutions in identifying and reporting potential sanctions evasion and other suspicious activity related to Iran

The Department of Commerce and the Nuclear Regulatory Commission published final rules today implementing an adjustment for inflation to False Claims Act civil penalties ...

To help our clients navigate the coronavirus (COVID-19) crisis, Arnold & Porter has established a Coronavirus Task Force covering a wide range of issues

In this third and final part of our AI series in collaboration with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Partner at Arnold & Porter; Mahnu Davar, Partner at Arnold & Porter; ...

On May 29, 2025, the Central Commission for Discipline Inspection of the Communist Party of China (CCDI, 中共中央纪律检查委员会 中华人民共和国国家监察委员会) announced that Jingquan Bi (毕井泉), the former Director of the National Medical Products Administration (NMPA, 国家药品监督管ச

The U.S. Food and Drug Administration, Center for Devices and Radiological Health (FDA) plays a pivotal role in shaping the future of medical technology innovation, particularly through its pre-market and post-market regulatory oversight.

On January 7, 2022, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule—to become effective 30 days after its...

Human factors are increasingly being recognised as an important element of medical devices, in particularly in relation to managing patient safety.

Yesterday, a new global medicines patent database, the Patent Information Initiative for Medicines (Pat-INFORMED), was launched by WIPO and the International Federation of Pharmaceutical Manufacturers

On December 23, 2019, the Food and Drug Administration (FDA) issued a proposed rule and draft guidance to implement and facilitate two pathways for the legal...

There are several aspects of the pharmaceutical industry's potential environmental footprint. Research and development require sophisticated equipment, controlled environments, and specialised materials.

In a report published on 16 July regarding the implementation of its flagship policy on the publication of clinical data (Policy 0070), the EMA has announced that Brexit and the Agency's relocation...

While the Clinical Trials Regulation (EU No. 536/2014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6 months ...

As previously discussed on this blog, in February a North Carolina jury found Brent Brewbaker, a former executive of Contech Engineered Solutions LLC, guilty of antitrust and fraud charges...

In this episode of Bona Fide Needs, Arnold & Porter Partner Mike McGill and PubKGroup Managing Editor Bill Olver cover a broad range of recent legal developments affecting government contractors.

The Trump Administration has expanded False Claims Act enforcement beyond traditional healthcare fraud into policy-driven areas like DEI programs and gender-affirming care, while simultaneously driving record-breaking conventional enforcement with 1,297 qui tam filings in FY 2025. Healthcare entities now face dual compliance demands as DOJ pursues both novel policy initiatives and traditional fraud priorities through enhanced data-mining capabilities and interagency coordination.

"The DOJ said…that they would be using the False Claims Act to enforce cybersecurity rules and regulations."