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FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

FDA Oks Mail-Order Mifepristone: State Laws May Inhibit Its Use

In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and...more

Is The Future Of Telehealth In OIG’s Hands?

Telehealth services may be at a crossroads. While the COVID-19 pandemic brought about widespread adoption of telehealth services, the Department of Justice and the U.S. Department of Health and Human Services Office of...more

Do You Have The COVID-19 Blues? Don’t Forget About Sunshine!

While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly,...more

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