TITLE

Regulations, economics hindering adoption of personalized medicine

AUTHOR(S)
Thompson, Cheryl A.
PUB. DATE
March 2011
SOURCE
American Journal of Health-System Pharmacy;3/1/2011, Vol. 68 Issue 5, p372
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article discusses the regulations and economics of the Medical Device Amendments of 1976, which pose a regulatory roadblock to the adoption of personalized medicine and diagnostics. It highlights that Section 510(k) of the Federal Food, Drug, and Cosmetic Act through which lower-risk medical devices enter the market. The article also discusses that the payer world prefers demonstrable outcomes and lower costs from coverage of a diagnostic test.
ACCESSION #
58638921

 

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