Predicting Drug–Drug Interactions: An FDA Perspective

Women in clinical trials: an FDA perspective.

Drug Administration (FDA) has been interested in the individualization of therapy, that is, determining whether and how treatment should be modified for various demographic groups within the population. After several years of discussion, a guideline was published on the study of drugs in the elderly (1), and later a similar guideline on the study and evaluation of gender differences in the clin...

Role of risk assessments in viral safety: an FDA perspective.

FDA perspective on anti-TNF treatments.

Although there are many points I would like to make about the FDA’s perspective on antiTNF treatments, I have limited myself to those 10 that I believe are most important. I present several of these less as absolutes than as stimulants for discussion, as I wish to make use of the expertise at this conference for furthering our collective understanding of how anti-TNF agents might best be used.

Additively manufactured medical products – the FDA perspective

Additive manufacturing/3D printing of medical devices is becoming more commonplace, a 3D printed drug is now commercially available, and bioprinting is poised to transition from laboratory to market. Despite the variety of technologies enabling these products, the US Food and Drug Administration (FDA) is charged with protecting and promoting the public health by ensuring these products are safe...

VARC consensus report: the FDA perspective†

The Food and Drug Administration (FDA) is responsible for protecting and promoting the public health of US citizens. In keeping with this mission, FDA’s Center for Devices and Radiological Health (CDRH) is tasked with assuring the safety, effectiveness, and quality of medical devices, assuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurat...