※追記更新（2018.04.14）
※追記更新（2018.06.02）
4/12付で米国FDAから「FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests」と題して、腫瘍をターゲットとする“Next Generation Sequencing (NGS)”関連の対外診断に関する新たなガイダンスを発出したとPress Releaseしています。
関係者及び興味の雨方は、下記URLsの通知・ガイダンス等をご参照ください。
●Press Release「FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests」
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604462.htm
●最終ガイダンス「Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics」
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM509837.pdf
●公報「Federal Register: Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics」
https://www.federalregister.gov/documents/2018/04/13/2018-07686/guidance-use-of-public-human-genetic-variant-databases-to-support-clinical-validity-for-genetic-and
●最終ガイダンス「Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases」
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM509838.pdf
●公報「Federal Register: Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing-Based In Vitro Diagnostics Intended to Aid in the Diagnosis of Suspected Germline Diseases」
https://www.federalregister.gov/documents/2018/04/13/2018-07687/guidance-considerations-for-design-development-and-analytical-validation-of-next-generation
●ウェビナー開催案内「Webinar - Final Guidances on Next Generation Sequencing-based Tests - May 24, 2018」
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm603766.htm
●関連情報「FDA Recognition of Public Human Genetic Variant Databases」
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/PrecisionMedicine-MedicalDevices/ucm603675.htm
また、同日(4/12)付で関連する腫瘍の対外診断に関するドラフトガイダンスも発出されています。
合せて、下記URLのドラフトガイダンスをご参照ください。
ドラフトガイダンス「Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination」
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM604441.pdf
また、本件発出に伴い、4/12付のRAPSが「Next-Generation Sequencing: FDA Offers Guidance to Streamline Path to Market 」と題して記事に取り上げています。
合せてお読み頂ければ、理解がより深まるものと思います。
本ニュース記事き、下記URLから閲覧可能です。
https://www.raps.org/news-and-articles/news-articles/2018/4/next-generation-sequencing-fda-offers-guidance-to
【4/14付追記更新】
4/13付で米国FDAから上記でお伝えした公報のテキスト版が公開されています。
ご参考まで。
●「Federal Register: Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing-Based In Vitro Diagnostics Intended To Aid in the Diagnosis of Suspected Germline Diseases; Guidance for Stakeholders and Food and Drug Administration Staff; Availability」
https://www.gpo.gov/fdsys/pkg/FR-2018-04-13/html/2018-07687.htm
●「Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff; Availability」
https://www.gpo.gov/fdsys/pkg/FR-2018-04-13/html/2018-07686.htm
【6/2付追記更新】
6/1付で米国FDAから上記でお伝えしたウェビナー「Webinar - Final Guidances on Next Generation Sequencing-based Tests - May 24, 2018 」の資料が公開されています。
興味のある方は、下記URL（上記でお伝えしたURLと同じです）の資料をご参照ください。
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm603766.htm
※追記更新（2018.06.02）
4/12付で米国FDAから「FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests」と題して、腫瘍をターゲットとする“Next Generation Sequencing (NGS)”
関係者及び興味の雨方は、下記URLsの通知・
●Press Release「FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests」
https://www.fda.gov/
●最終ガイダンス「Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics」
https://www.fda.gov/downloads/
●公報「Federal Register: Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics」
https://www.federalregister.
●最終ガイダンス「Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases」
https://www.fda.gov/downloads/
●公報「Federal Register: Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing-Based In Vitro Diagnostics Intended to Aid in the Diagnosis of Suspected Germline Diseases」
https://www.federalregister.
●ウェビナー開催案内「Webinar - Final Guidances on Next Generation Sequencing-based Tests - May 24, 2018」
https://www.fda.gov/
●関連情報「FDA Recognition of Public Human Genetic Variant Databases」
https://www.fda.gov/
また、同日(4/12)付で関連する腫瘍の対外診断に関するドラ
合せて、下記URLのドラフトガイダンスをご参照ください。
ドラフトガイダンス「Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination」
https://www.fda.gov/downloads/
また、本件発出に伴い、4/12付のRAPSが「Next-
合せてお読み頂ければ、理解がより深まるものと思います。
本ニュース記事き、下記URLから閲覧可能です。
https://www.raps.org/news-and-
【4/14付追記更新】
4/13付で米国FDAから上記でお伝えした公報のテキスト版が
ご参考まで。
●「Federal Register: Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing-Based In Vitro Diagnostics Intended To Aid in the Diagnosis of Suspected Germline Diseases; Guidance for Stakeholders and Food and Drug Administration Staff; Availability」
https://www.gpo.gov/fdsys/pkg/
●「Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff; Availability」
https://www.gpo.gov/fdsys/pkg/
【6/2付追記更新】
6/1付で米国FDAから上記でお伝えしたウェビナー「Webi
興味のある方は、下記URL（上記でお伝えしたURLと同じです
https://www.fda.gov/
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
コメント
/
/
/
コメント