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On the Attack: FDA Pursues Online Retail Fulfillment House

In an unprecedented move, the U.S. Food and Drug Administration (FDA or Agency) sent a warning letter to Amazon.com, Inc. (Amazon), a fulfillment house, with respect to distributing over-the-counter (OTC) drug products that...more

A Target on Telehealth: Government Action Against Telehealth Fraud in the Wake of COVID-19

The COVID-19 Public Health Emergency (PHE) is expected to prompt unprecedented levels of regulatory enforcement activity that is focused on the use of telemedicine. In fact, fraudulent and abusive telehealth practices was an...more

Latest Open Payments Data Released Under Heightened Government Scrutiny

On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

Clinical Trials: Does FDA’s Notice to Acceleron Signal a New Era of Enforcement for Results Reporting?

On April 27, 2021, the U.S. Food and Drug Administration (FDA) sent a notice of noncompliance to Acceleron Pharma (Acceleron), accusing the company of failing to post clinical trial summary results on its cancer combination...more

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