FDA To Regulate Direct-to-Consumer Genetic Tests
نویسندگان
چکیده
منابع مشابه
FDA to regulate direct-to-consumer genetic tests.
began, genetic tests were available for about 100 diseases — most of them caused by just one faulty gene, such as the mutations that cause Tay-Sachs and cystic fi brosis. As genomic technologies matured and sequencing became less costly, companies began developing tests for a wider range of complex, multigenic, common diseases. These were initially offered by laboratories used by physicians, bu...
متن کاملThe regulation of direct-to-consumer genetic tests.
The past year has been marked by the emergence of several companies, such as 23andMe, deCODEME, Navigenics and Knome, offering tests using genome-wide technology direct to consumers over the internet. On the basis of the published research findings of GWAS and other studies, these companies will calculate an individual's risk to a number of common diseases, without the necessity of going throug...
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In August, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) sought to curb growing public criticism over its consumer advertising practices by releasing voluntary advertising guidelines. The document stated that drug advertising should serve the public health by “ increasing awareness about diseases ” and “ educating patients about treatment options. ” The voluntary PhRMA gui...
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Background For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a...
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Yes Vote Message: a cohort receives a VOTE REQ, and it responds by sending a yes or no vote message (Yes or NO VOTE, Yes Vote also known as PREPARED message) to the coordinator (Shanker, Misra, & Sarje, 2009a) Yet Another Workflow Language (YAWL): a process modelling and execution language based on the workflow patterns and Petri nets. YAWL is also the name of the corresponding workflow system ...
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ژورنال
عنوان ژورنال: JNCI Journal of the National Cancer Institute
سال: 2010
ISSN: 0027-8874,1460-2105
DOI: 10.1093/jnci/djq446