During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of important medical devices. On December 23, 2021, FDA published two draft guidances setting forth the Agency’s proposed process for…
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new drugs and biological products in 2021 (not including the vaccines, cellular and gene therapy products, or other products approved in 2021 by the Center for Biologics Evaluation and Research). As in past years, small molecule drug approvals dominated…
During the COVID-19 pandemic, decentralized clinical trials and remote patient monitoring and data acquisition became a necessity, accelerating the use of digital health technologies in clinical trials. Acknowledging that technological advances “have revolutionized the ability to remotely obtain and analyze clinically relevant information from individuals” and that “DHTs [ ]…
The final rules regarding special compensation under 42 U.S.C. § 1395nn, the Physician Self-Referral or Stark Law, go into effect on January 1, 2022 and will require many physician group practices to modify their compensation methodologies, specifically the pooling and distribution of profits for the provision designated health services (“DHS”)….
Last week the FDA issued another draft guidance in its series of recent guidance documents setting forth the agency’s views regarding the generation and use of Real-World Data (RWD) and Real-World Evidence (RWE) for prescription drugs and biological products. (see our recent post on FDA’s draft guidance relating to registries)….
Today, developers of innovative medical devices are increasingly utilizing artificial intelligence (AI) and machine learning (ML) technologies to derive important insights with the promise of transforming the delivery of healthcare. Yet, concerns regarding the transparency of AI/ML-enabled devices, or the degree to which information about such devices is communicated to…
The Department of Justice recently announced the launch of its new Civil Cyber-Fraud Initiative (the “Initiative”) which intends to use the False Claims Act to pursue “cybersecurity-related fraud by government contractors and grant recipients.” Specifically, the Initiative will target those who: knowingly provide deficient cybersecurity products or services, knowingly misrepresenting…
Showing no signs of food coma, the FDA issued draft guidance on the Monday following the Thanksgiving holiday weekend that outlines considerations for sponsors proposing to design a registry or use an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. This draft guidance represents the Agency’s…
Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016. For full text of the bill, click here. The 21st Century Cures Act included a variety of measures…
On October 28, a majority of members on the Senate Judiciary Committee voted 15-7 to advance to the full Senate a bipartisan bill that would make a number of amendments to the False Claims Act (“FCA”), including one that would make significant changes to the FCA’s definition of “materiality.” Senator…
