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BioArray News Coverage of FDA and Microarrays
Aug 13, 2003
Roche and Two Others Suggest a New Class of ASR: In Vitro Analytical Tests [BN, 8/6/2003]
OIVD’s Steve Gutman Says FDA Plans to Consider Changing ASR Regulations [BN, 7/23/2003]
Microarray Industry Keeps an Eye on FDA’s Approach to Roche AmpliChip [BN 7/16/2003]
FDA’s Weida Tong Discusses Tracking of Toxicology Microarray Data [BN 7/16/2003]
BREAKING NEWS: FDA to Roche: Your Presence is Requested. Agency Letter Seeks to Discuss AmpliChip [BN 7/10/2003]
FDA Conducting Two Test Projects to Get Better Acquainted with Microarray Data [BN 6/25/2003]
FDA Gates Swinging Open To Admit Standardized Gene Expression Data [BN 6/18/2003]
CDER’s Woodcock: FDA To Publish Draft Guidance in August on Array Data in INDs [BN 6/4/2003]
Expertech’s David Link on the FDA, In Vitro Diagnostic Regulations [BN 6/4/2003]
New FDA Draft Guidance for IVD is First For Industry in More Ways Than One [BN 5/28/2003]
Roche Reshapes Affy’s GeneChip As AmpliChip: Readies a CYP450 ASR [BN 4/25/2003]
FDA Testing of Iconix DataMatrix Is Another Step Forward for Microarrays [BN 3/21/2003]
FDA Preparing Draft Document to Help Guide Microarray Data Consideration [BN 3/14/2003]
