This article discusses the U.S. Food and Drug Administration's draft guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices.
This article discusses the friendly-PC model, which is a common structure designed to comply with state corporate practice of medicine doctrines. The friendly-PC model involves a professional service corporation (PSC) conducting a medical practice in affiliation with a management services organization (MSO).
Although the friendly-PC model may be a solution to the corporate practice of medicine doctrine, it can create unintended consequences for employee benefit plans sponsored by the PSC and MSO.
This article discusses the US Drug Enforcement Agency's (DEA) new regulation temporarily extending the “full set” of COVID-19 waivers for prescribing controlled substances via telemedicine.
Originally published by Foley & Lardner LLP on May 11, 2023.
In this multi-jurisdictional guide, explore an overview of key legal issues, rules and developments regarding pharmaceutical advertising across a range of jurisdictions.
This article discusses the ruling by a California Court of Appeal that ultimately determined a hospital's decision to terminate an employee for failing to comply with its flu vaccine mandate did not violate California's Fair Employment and Housing Act (FEHA).
This blog focuses on U.S. Food and Drug Administration (FDA) published framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials. DHTs include a wide array of technologies, including software applications that run on a phone, wearables, and environmental sensors, among others. As DHT becomes more sophisticated, the technologies have the potential to play an even larger role in health care, including clinical research.
This blog explores the U.S. Food & Drug Administration (FDA) two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19 Public Health Emergency (PHE), and (ii) that were issued emergency use authorizations (EUAs). These guidance documents finalize the corresponding draft guidance documents that were issued on December 23, 2021.
This blog explores physician recapitalization transactions and how complex they are and their myriad issues. At Foley, in our representation of both investors in, and sellers of, physician practices, we note how often tax issues become gating items that drive the structural aspects of the transaction.