Date: December 10, 2015
The following new items were added to the CDRH web pages on December 9, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Letter to Genomic Express, Inc. concerning pharmacogenomic tests
- Letter to Healthspek LLC concerning the Healthspek PGT test for genes affecting drug metabolism
- Meeting Minutes posted for FDA-Industry MDUFA IV Reauthorization Meeting, November 18, 2015
- Federal Register: Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Guidance for Industry and Food and Drug Administration Staff; Availability
- Federal Register: Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing in Vitro Diagnostic Tests; Public Workshop; Reopening of Comment Period
- Federal Register: Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants; Public Workshop; Reopening of Comment Period