FDA Guidance on Genetic Tests
On November 6, 2006, Genetic Alliance hosted a forum on the FDA’s recent draft guidances on Analyte Specific Reagents (ASRs) and In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). In this two-hour free webinar, Janet Woodcock, MD, FDA Deputy Commissioner for Operations, described the guidances. Representatives of research, clinical care, industry, and laboratories, including Mara Aspinall, Kathy Hudson, David Mongillo, and Mike Watson, responded. Participants had a chance to ask questions and share insights.
View the slides from Janet Woodcock and Kathy Hudson.
Read the major points presented by the panelists.
See the transcript of questions asked and answered during the webinar.
See questions answered by panelists after the webinar.
View webinar survey results.
See bios and professional affiliations for discussion leaders below.
Moderator: Sharon Terry
Presenters:
Janet Woodcock – Deputy Commissioner for Operations, Food and Drug Administration
Mara Aspinall – President, Genzyme Genetics
Kathy Hudson – Director, Genetics and Public Policy Center
David Mongillo – Vice President for Policy and Legislative Affairs, American Clinical Laboratory Association
Mike Watson – Executive Director, American College of Medical Genetics
Mara Aspinall – President, Genzyme Genetics
Kathy Hudson – Director, Genetics and Public Policy Center
David Mongillo – Vice President for Policy and Legislative Affairs, American Clinical Laboratory Association
Mike Watson – Executive Director, American College of Medical Genetics
Genetic tests are among the first line of products applicable to our lives in the Genomic Era. We, consumers of those tests, must ensure they are accessible, accurate, and reliable. Make sure your voice is heard—we are here to help you do that!
