Acronym of the week would be more accurate, but GDUFA will be used as a word so it might as well be defined as one. With the passage of the Food and Drug Administration Safety and Innovation Act on July 9, 2012, GDUFA (‘Generic Drug User Fee Amendments...
“Ome” has become for molecular biology what “gate” is to American scandal – a shorthand suffix that links a new concept or event to an original (“genome”, “Watergate”).
The current (February) issue of Nature Reviews: Drug Discovery contains a “comment” (http://www.nature.com/nrd/journal/v11/n2/pdf/nrd3659.pdf) from Isaac Kohane, M.D., Ph.D., of the Harvard Medical School Center for Biomedical Informatics, who cautions that not all associations observed in a genome-wide association study are pertinent – some are just incidental. Of the millions of genetic variations measurable in a single human genome, even with the best editing most people will have at least one false positive test. Similarly, by using increasingly minor genetic variations to custom tailor drug dosing, the added perceived precision may inadvertently result in underdosing or toxic overdosing.
A suggested near-term step toward providing context for genetic variations is more effective mining of post-approval drug studies to merge genetic observations with adverse events and drug levels to arrive at “expert-vetted” recommendations for dosage adjustments.
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