FDA on lab test regulation
This article was originally published in The Gray Sheet
Executive Summary
FDA says it has not yet resolved issues raised in a Dec. 5 citizen petition from biotech firm Genentech that asks the agency to regulate all laboratory-developed tests. The petition "raises issues requiring further review and analysis by agency officials," CDRH Acting Associate Director for Regulation and Policy Catherine Cook writes in a June 15 interim response posted online July 11. Genentech is urging FDA to apply its current risk-based classification to determine the necessary level of regulatory oversight and review, and to sanction labs or firms that are selling lab-developed tests without sufficient analytical and clinical evidence to support therapeutic claims (1"The Gray Sheet" Dec. 22, 2008). FDA says it will respond with a final decision at a later date
You may also be interested in...
Genentech Petition Rekindles Debate On Lab-Developed Test Regulation
A citizen petition from biotech giant Genentech is adding new fire to the debate over whether FDA should regulate more laboratory-developed tests, and under what authority
Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States
Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.
Metsera Launches As New Obesity Contender Flush With $290m
Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture.