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FDA Eases Device Modification Rules to Expand Availability of Ventilators During COVID-19 Pandemic

USA - March 24 2020 On March 22, 2020, the U.S. Food and Drug Administration (“FDA”) issued guidance, for immediate implementation, that aims to increase the…

Ashley Creech

OIG Permits Manufacturer of Personalized Medicine Drug to Cover Patients’ Travel, Lodging, and Other Expenses

USA - January 29 2020 On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02…

Jennifer E. Michael

What’s New in E-Cigarette Regulation?

USA - August 14 2019 There is little question that youth e-cigarette use has been on the rise. In 2018, an estimated 3.6 million kids reported “current use” of…

The Role of Patient Preference in Medical Device Evaluation

USA - May 23 2019 When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA…

Obscure FDA Device Reporting Exemptions Draw Patient and Provider Concern

USA - March 28 2019 Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t…