FDA Wants More Consumer Information Available

As part of the HHS regulatory priorities for FY 2018, FDA will amend its regulations on the information patients receive for outpatient-administered prescription drugs. And to encourage more consumer-directed care, the agency plans to propose regulations to facilitate access to more treatments for common conditions by using new approaches, including new technologies, to assist consumers in self-selection and use of products that have previously been available only by prescription.

Other FDA priorities listed in the HHS document are: 

•          proposing a new rule that will modernize mammography quality by recognizing new technologies, making improvements in facility processes, and the reporting of breast density, which is now widely recognized as a risk factor for breast cancer; and
•         updating important rules for medical device applications so that the rules reflect risk-based and least burdensome pathways to market for devices, including new and innovative devices.