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Journals and Conferences
As more research studies incorporate next-generation sequencing (including whole-genome or whole-exome sequencing), investigators and institutional review boards face difficult questions regarding which genomic results to return to research participants and how. An American College of Medical Genetics and Genomics 2013 policy paper suggesting that… (More)
While diabetes mellitus types 1 and 2 used to be distinguished largely by age at onset, in the past decade there has been an increase in the number of children presenting with diabetes that can be controlled with oral medications. This has lead to these children being diagnosed with type 2 diabetes mellitus despite their young age. This chapter offers an… (More)
The Food and Drug Administration (FDA) recently advanced two draft guidances1,2 proposing a regulatory framework for laboratory-developed tests, a category that includes many but not all genomic tests. The FDA convened a workshop in February 2015 to discuss the oversight of nextgeneration sequencing.3,4 President Barack Obama’s Precision Medicine Initiative… (More)
The return of individual results to research participants has been vigorously debated. Consensus statements indicate that researchers and bioethicists consider the return of research results most appropriate when the findings are clinically relevant. Even when clinical utility is the motivator, however, the return of individual research results is not… (More)
"The expression 'barbarians at the gate' was … used by the Romans to describe foreign attacks against their empire." 1 "[It] is often used in contemporary English within a sarcastic, or ironic context, when speaking about a perceived threat from a rival group of people, often deemed to be less capable or somehow 'primitive.'" 2.
D irect-to-consumer (DTC) personal genome tests claim to provide consumers access to information about their genetic ancestry, susceptibility to traits such as excessive earwax, carrier status for diseases like cystic fi brosis, ability to metabolize drugs like statins, and likelihood of developing diseases such as cancer, Alzheimer’s disease, and… (More)
The US Food and Drug Administration (FDA) Amendments Act of 2007, when fully implemented, will offer new sources of evidence and new regulatory mechanisms during the postmarket phase of drug life. If artfully and carefully applied, these new capabilities could help resolve problems that have long impeded the clinical translation of pharmacogenomics.
Protecting the public from faulty targeting of medicines, while preserving the crucial distinction between product and practice regulation, may require innovative regulatory approaches and close, ongoing involvement by the medical profession. This article explores four problem areas: validation of clinical claims for tests used in targeting therapies;… (More)