Ohio Mental Health & Addiction Services (OMHAS) has issued guidance to support Ohio opioid treatment programs (OTPs) in light of the COVID-19 (coronavirus) outbreak....more
Makers, distributors, program planners and administering entities of coronavirus (COVID-19) countermeasures are protected from liability under a declaration issued by the Department of Health and Human Services (HHS)...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
Healthcare providers have special concerns for their employees during the Coronavirus (COVID-19) global health emergency....more
Cardinal Health (“Cardinal”) agreed to pay the SEC $8.8 million for FCPA violations in China relating to its internal controls and books and records. Cardinal acknowledged facts relating to internal controls deficiencies and...more
Cardinal Health Inc. (Cardinal) settled its Foreign Corrupt Practices Act (FCPA) matter with the Securities and Exchange Commission (SEC) last week. According to the SEC Press Release, Anita B. Bandy, Associate Director in...more
How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more