FDA User Experience Study Archives

Decoding FDA DTC Policy: Part 1 – Pharmacogenetics Are Here!

by Scott D. Crawford | Nov 12, 2018

While many of us were heading out to dish out candy (or tricks) to local goblins and superheroes this past Halloween, the FDA rounded out their suite of De Novo reclassification orders on DTC genetic testing. The latest announcement adds Personal Genome Service Pharmacogenetic Reports (PGSPR) to the existing regulations for Carrier Screening and Genetic Health Risk (GHR) tests (including a specific case of Genetic Health Risk Report for BRCA1/BRCA2)…

Gathering data for direct-to-consumer personal genomic testing made easier with SoundRocket as data collection partner

by Scott D. Crawford | Feb 28, 2018

This was the first experience for any researchers to look closely at the impact of personal genetic testing reports – to see how users understood them and made use of the results they provide. Soundrocket was happy to play a role in this important research.

FDA Genetic Health Assessment Ruling: Decoded

by SoundRocket | Dec 12, 2017

Trying to read and understand the latest FDA release on personal genetic testing (or what they are now calling Genetic Health Assessments)? Wish that they could indent when they use multi-level outlines? We have created a version that may be a bit easier to read and understand…

FDA User Experience Study

Decoding FDA DTC Policy: Part 1 – Pharmacogenetics Are Here!

Gathering data for direct-to-consumer personal genomic testing made easier with SoundRocket as data collection partner

FDA Genetic Health Assessment Ruling: Decoded

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