FDA TELECONFERENCE ADVISORY Today @ 11 am EST
Office of Health and Constituent Affairs
Food and Drug Administration
U.S. Department of Health and Human Services
FDA Draft Guidances for Next-Generation Sequencing Tests
Dear Colleague,
We are pleased to announce that the FDA has published draft guidances that would streamline submission and review of data supporting the clinical and analytical validity of NGS-based tests. They represent a significant step, working within FDA’s existing regulatory authority, toward the FDA’s long-term goal of establishing a dynamic and flexible regulatory approach for genomic tests. We request that you review the guidances on our website http://www.fda.gov/NewsEvents/Newsro.../ucm509814.htm.
We incorporated insights from patient and provider groups, test developers, industry coalitions, professional societies, and leading academicians, and from four public meetings. The first draft guidance, entitled “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” provides recommendations for designing, developing and validating NGS-based tests for hereditary diseases, and addresses the potential for using FDA-recognized standards to demonstrate analytical validity.
The second draft guidance, entitled “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” describes an approach for test developers to use data from public genomic databases that meet certain criteria and gain FDA recognition. Data and assertions from these FDA-recognized databases could help ensure accurate clinical interpretations of genomic test results and support clinical claims in marketing submissions.
The guidances explain how the FDA would consider, in the future, whether to exempt certain NGS-based tests from premarket review. This system would be efficient and flexible: as technology advances, standards can be updated to help ensure test accuracy. Similarly, as clinical evidence improves, new interpretations could be supported. This adaptive approach would ultimately foster innovation among test developers and improve patients’ access to these new technologies.
The FDA invites you to participate in our stakeholder call scheduled for July 7, 2016 at 11 a.m. EST. The toll-free number for the call is: 800-369-1193, international callers may call on: 1-415-228-4959, the passcode is: FDA. A replay of the call will be available until August 7, 2016 on: 866-373-1992, international callers may hear the replay on: 1-203-369-0266.
We look forward to your participation on the stakeholder call scheduled for July 7 at 11 a.m. EST; additionally, FDA will also be hosting informational webinars regarding these draft guidances soon. As they are scheduled we will update you with additional information. Also, if you or your organization plan to issue a statement about FDA’s announcement, would you please forward it to me to the email address below.
Sincerely,
Heidi C. Marchand, Pharm.D.
Assistant Commissioner
Office of Health & Constituent Affairs
Office of External Affairs
U.S. Food and Drug Administration
Tel: 301-796-8457 / Main Off: 301-796-8460
[email protected]
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Office of Health and Constituent Affairs
Food and Drug Administration
U.S. Department of Health and Human Services
FDA Draft Guidances for Next-Generation Sequencing Tests
Dear Colleague,
We are pleased to announce that the FDA has published draft guidances that would streamline submission and review of data supporting the clinical and analytical validity of NGS-based tests. They represent a significant step, working within FDA’s existing regulatory authority, toward the FDA’s long-term goal of establishing a dynamic and flexible regulatory approach for genomic tests. We request that you review the guidances on our website http://www.fda.gov/NewsEvents/Newsro.../ucm509814.htm.
We incorporated insights from patient and provider groups, test developers, industry coalitions, professional societies, and leading academicians, and from four public meetings. The first draft guidance, entitled “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” provides recommendations for designing, developing and validating NGS-based tests for hereditary diseases, and addresses the potential for using FDA-recognized standards to demonstrate analytical validity.
The second draft guidance, entitled “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” describes an approach for test developers to use data from public genomic databases that meet certain criteria and gain FDA recognition. Data and assertions from these FDA-recognized databases could help ensure accurate clinical interpretations of genomic test results and support clinical claims in marketing submissions.
The guidances explain how the FDA would consider, in the future, whether to exempt certain NGS-based tests from premarket review. This system would be efficient and flexible: as technology advances, standards can be updated to help ensure test accuracy. Similarly, as clinical evidence improves, new interpretations could be supported. This adaptive approach would ultimately foster innovation among test developers and improve patients’ access to these new technologies.
The FDA invites you to participate in our stakeholder call scheduled for July 7, 2016 at 11 a.m. EST. The toll-free number for the call is: 800-369-1193, international callers may call on: 1-415-228-4959, the passcode is: FDA. A replay of the call will be available until August 7, 2016 on: 866-373-1992, international callers may hear the replay on: 1-203-369-0266.
We look forward to your participation on the stakeholder call scheduled for July 7 at 11 a.m. EST; additionally, FDA will also be hosting informational webinars regarding these draft guidances soon. As they are scheduled we will update you with additional information. Also, if you or your organization plan to issue a statement about FDA’s announcement, would you please forward it to me to the email address below.
Sincerely,
Heidi C. Marchand, Pharm.D.
Assistant Commissioner
Office of Health & Constituent Affairs
Office of External Affairs
U.S. Food and Drug Administration
Tel: 301-796-8457 / Main Off: 301-796-8460
[email protected]
U.S. Food and Drug Administration Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube View FDA photostream on Flickr Subscribe to FDA RSS feeds
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