2020

On February 21, 2020, the US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning…

Recently, the U.S. Food and Drug Administration (FDA) released a guidance that accelerated the ability for certain laboratories to…

With the world in the throes of the COVID-19 pandemic, Rockpointe, a leading continuing medical education (CME) creator in …

In January 2020, the United States Court of Appeals for the District of Columbia heard arguments in Merck & Co., Inc. v. HHS,…

The Department of Health and Human Services (“HHS”) recently issued a declaration under the Public Readiness and Emergency…

Following a public meeting at the United States Food and Drug Administration (FDA) in November 2019, a handful of drug makers sent…

Many clinical trial sponsors are failing to comply with mandatory reporting requirements, and are breaking the law in the process.…

The US Food and Drug Administration (“FDA”) recently issued a Manual of Policies and Procedures (“MAPP”) describing how the Center…

The novel coronavirus (also known as COVID-19) has been dominating the news media coverage these last few weeks. We don’t know…

Earlier this year, the United States Centers for Medicare and Medicaid Services (CMS) announced a few new updates and milestones…