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FDA Publishes Concept Paper on Development of Theranostics

NEW YORK, April 11 (GenomeWeb News) - The Food and Drug Administration on Friday issued a "concept paper" on how drugs and accompanying diagnostics should be co-developed "in a scientifically robust and efficient way."


The paper is the first step on the way to a formal guidance on the co-development of drugs and diagnostics. The FDA said it intends to seek comments from the public on the concept paper first, then develop a draft guidance for public comment.


Like the Pharmacogenomics Data Submission Guidance that the agency released last month, a similar so-called "theranostics" guidance could help encourage drug and diagnostics companies to invest in new pharmacogenomics technologies.


According to the FDA, the paper "contains general ideas on both process and scientific issues to be considered in the co-development of drugs in which a new diagnostic test may play a critical role in the clinical use of the drug."


Specifically, the new document addresses the development of in vitro diagnostics for mandatory use in decision making about drug selection for patients. It does not include the use of pharmacogenomic testing for drug dosing or monitoring of drugs, "although it does contain principles that may be relevant to the development of these types of tests," according to the paper.


To view the complete concept paper, click here.

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