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Given the increasing pressure (17) for the FDA to extend the more rigorous regulatory mechanisms of 510(k) and premarket approval (PMA) registration to cover these LDTs (thereby significantly increasing the cost to laboratories offering them, and weeding out poorly validated and perhaps unapprovable analytes), it is in fact possible that the total number ofprotein tests offered clinically could decline substantially over the next few years.
We accept the disadvantages, namely that the same body will review protocols twice from slightly different perspectives and that certain categories of research will remain unapprovable.
The FDA letter cites the information submitted by Matrix to be inadequate and said that the AccuSite application is consequently unapprovable as submitted.
Specifically, the Company faces risks and uncertainties associated with the Company's indiplon program and planned commercialization activities, including but not limited to; risk that regulatory authorities find our indiplon NDAs incomplete or insufficient or otherwise unapprovable or that approvals may be delayed; risk associated with our reliance on our strategic alliance partner for manufacturing and commercialization of indiplon; risk that following approval of indiplon commercialization may be delayed for any of a number of reasons including market conditions and product supply; risk that the indiplon labeling granted by regulatory authorities may limit the commercial success of indiplon; and risk relating to market acceptance of indiplon following marketing approval.