FDA’s latest ASR guidance document creates more confusion and raises legal issuesApril 21, 2008
In September 2006, FDA issued a draft document, “Guidance for Industry and FDA Staff-Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.” Even though FDA issued the final guidance document one year later, its release has not ended the controversy over how ASRs should be regulated.1
This article summarizes some of the substantive elements of the final ASR guidance document and their impact. The article also discusses some of the procedural issues that have emerged.
1. “Guidance for Industry and FDA Staff-Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions,” FDA (Rockville, MD: 2007 [cited 22 February 2008]); available from Internet: www.fda.gov/cdrh/oivd/guidance/1590.pdf
Additional information available here.