From the LaunchPad

Welcome to The Launchpad, SoundRocket’s blog, where we share our insights and musings on the science of doing science (well), #soundscience.

Categories

Decoding FDA DTC Policy: Part 3 – The November 1 Warning Shots

Decoding FDA DTC Policy: Part 3 – The November 1 Warning Shots

One day following the Personal Genome Service Pharmacogenetic Reports (PGSPR) approval release, on Thursday, November 1, 2018, Jeffrey Shuren, M.D., J.D. (the Director of the FDA’s Center for Devices and Radiological Health), together with Janet Woodcock, M.D., (the Director of the FDA’s Center for Drug Evaluation and Research) published a statement to warn “consumers about genetic tests that claim to predict patient’s responses to specific medications.”  This statement specifically calls out tests…

read more
Decoding FDA DTC Policy: Part 2 – What are user comprehension studies? And are pharmacogenetic test report requirements different than previous FDA regulations?

Decoding FDA DTC Policy: Part 2 – What are user comprehension studies? And are pharmacogenetic test report requirements different than previous FDA regulations?

What Are User Comprehension Studies and Why are they Required by the FDA?

Unlike tests that are overseen by health care professionals where a conversation may take place about the meaning of results, direct-to-consumer tests bypass the traditional patient-doctor relationship and deliver results directly to patients (or consumers).  A well-known example of a direct-to-consumer test is a pregnancy test that one may purchase at any pharmacy or similar retail store…

read more