FDA

Recently, the United States Food and Drug Administration (FDA) finalized additional questions and answers related to biosimilar…

In September 2021, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would withdraw a Trump-era…

In late September 2021, the United States Food and Drug Administration (FDA) issued draft guidance, Real-World Data: Assessing…

The opioid epidemic that has gripped the US for over 20 years has worsened during the ongoing COVID-19 pandemic with the highest…

The US Food and Drug Administration (FDA) recently asked for input from stakeholders on how it should handle certain drugs…

On August 9, 2021, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent its…

Recently, the United States Food and Drug Administration (FDA) announced a public workshop to discuss mandatory prescriber…

After the controversial FDA approval of Aduhelm, Biogen’s Alzheimer’s disease therapy, the agency’s acting commissioner is calling…

In late July 2021, the United States Food and Drug Administration (FDA) finalized guidance on expectations for field alert reports…

The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an untitled letter…