Substantive Topics

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

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

by | Nov 14, 2018

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…

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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?

by | Nov 13, 2018

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…

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

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

by | 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)…

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Assessing event-based college student drinking and social context using mobile devices

Assessing event-based college student drinking and social context using mobile devices

by | Apr 12, 2018

Most surveys of alcohol-use ask about behaviors and patterns that happen days, weeks months or even years ago. It’s all retrospective recollection from study participants. It’s useful for identifying general trends but it’s fraught with measurement errors.  And when the topic of the study is binge drinking, errors involving memory can increase. — even if you’re asking the question the next day.

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Examining the Feasibility of Using SMS When Surveying College Students

Examining the Feasibility of Using SMS When Surveying College Students

by | Apr 11, 2018

ext messages (also known as Short Message Service, or SMS) are more and more becoming the go-to medium of communication. This especially is the case for today’s college students, who seem to conduct their social and even business lives completely via their smartphone.

Scott Crawford and the team at SoundRocket looked at the data surrounding the efficacy of using SMS when surveying college students, resulting in a presentation at the 2013 American Association of Public Opinion Research (AAPOR) Conference.

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FDA Genetic Health Assessment Ruling: Decoded

FDA Genetic Health Assessment Ruling: Decoded

by | 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…

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Sexual Assault Survey Now Available for Multi-institutional Enrollment

Sexual Assault Survey Now Available for Multi-institutional Enrollment

by | Apr 6, 2016

A collaborative partnership between the University of Michigan and SoundRocket now offers colleges and universities across the nation affordable access to a national campus climate survey measuring sexual assault. Piloted at the University of Michigan in Ann Arbor during the Winter 2015 term, the NCCS successfully measured what was previously thought of as unattainable in college student surveys.  The survey achieved a final response rate of approximately 67%, demonstrating how a comprehensive and responsive survey design can be implemented to achieve a more balanced and representative collection of responses.

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