On May 10, 2023, the Center for Medicare & Medicare Services (“CMS”) issued guidance to clarify the definition of “marketing” for Medicare Advantage Plans (“MA Plans”) and Prescription Drug Plans (“PDPs”).1 The new definition expands “marketing” to include activities intended to draw a consumer’s attention to an MA Plan or PDP, influence a consumer’s decision-making process, or influence a consumer’s decision to stay enrolled in an MA Plan or PDP. This new definition of marketing […]

Last month, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The publication of this digital health technology (DHT) framework fulfills an FDA commitment under the seventh iteration of the Prescription Drug User Fee Act reauthorization (PDUFA VII).

What Are DHTs?

In […]