Medical Economics: End the FDA (Food and Drug Administration)

Recent Actions by the Food and Drug Administration (FDA)

Memorandum of understanding between the Food and Drug Administration and the Defense Alliance for Advanced Medical Terminology--FDA. Notice.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Defense Alliance for Advanced Medical Terminology (DAAMT). The purpose of the MOU is to enable government agencies to exchange information and jointly pursue research endeavors related to medical device safety and effectiveness.

Physician Awareness and Utilization of Food and Drug Administration (FDA)-Approved Labeling for Pharmacogenomic Testing Information

We surveyed 10,303 United States physicians on where they obtain pharmacogenomic testing information. Thirty-nine percent indicated that they obtained this from drug labeling. Factors positively associated with this response included older age, postgraduate instruction, using other information sources, regulatory approval/ recommendation of testing, reliance on labeling for information, and per...

Food and Drug Administration (FDA)'s impact on laboratory performance: FDA's perspective.

The Division of Clinical Laboratory Devices is responsible for the premarket review of in vitro diagnostic devices (laboratory tests). We currently process >1000 diverse applications per year. New versions of old devices are handled as premarket notifications, so-called 510(k) submissions. The review objective is to establish that the new product is "substantially equivalent" to its predicate. ...

When Are Medical Apps Medical? Off-Label Use and the Food and Drug Administration

People have a love/hate relationship with rapidly changing healthcare technology. While consumer demand for medical apps continues to grow as rapidly as does supply (there are over 100,000 health, wellness and medical applications, or ‘apps’ on the market), healthcare professionals and safety experts worry about the impact of these apps on the health consumer. In response to the rapidly growing...