10/2で米国FDAから、ジェネリック医薬品申請（ANDA）関係の企業向けガイダンス等の通知が多数発出されています。
これらは、6/21付の米国FDAによる「FDA Working to Lift Barriers to Generic Drug Competition」としたFDA長官のステートメントに関連するものです。
https://blogs.fda.gov/fdavoice/index.php/2017/06/fda-working-to-lift-barriers-to-generic-drug-competition
10/2付で発出されたものは、以下のものです。
●「ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry」
http://raps.org/Regulatory-Focus/News/2017/10/02/28582/FDA-Targets-Complex-Generic-Drugs-With-New-Draft-Guidance/
●「ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers Guidance for Industry」
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578371.pdf
●「ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry」
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578371.pdf
●「Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry」
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM578366.pdf
●「Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability」
https://www.federalregister.gov/documents/2017/10/03/2017-21190/formal-meetings-between-the-food-and-drug-administration-and-abbreviated-new-drug-application
●「CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA」
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm578397.htm
●参考Federal Register「Abbreviated New Drug Applications Submissions-Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability」
https://www.federalregister.gov/documents/2017/10/03/2017-21175/abbreviated-new-drug-applications-submissions-amendments-to-abbreviated-new-drug-applications-under
また、これらについて、10/2付でFDA長官Scott Gottlieb氏が「Reducing the Hurdles for Complex Generic Drug Development」と題して、ステートメントを発信しています。
https://blogs.fda.gov/fdavoice/index.php/2017/10/reducing-the-hurdles-for-complex-generic-drug-development/
なお、今回のANDA関係のガイダンス等の発出に伴い、10/2付のRAPSが「FDA Targets Complex Generic Drugs With New Draft Guidance」と題して記事に取り上げています。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、理解が深まるものと思います。
http://raps.org/Regulatory-Focus/News/2017/10/02/28582/FDA-Targets-Complex-Generic-Drugs-With-New-Draft-Guidance/
これらは、6/21付の米国FDAによる「FDA Working to Lift Barriers to Generic Drug Competition」としたFDA長官のステートメントに関
https://blogs.fda.gov/
10/2付で発出されたものは、以下のものです。
●「ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry」
http://raps.org/Regulatory-
●「ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers Guidance for Industry」
https://www.fda.gov/downloads/
●「ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA Guidance for Industry」
https://www.fda.gov/downloads/
●「Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry」
https://www.fda.gov/downloads/
●「Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability」
https://www.federalregister.
●「CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA」
https://www.fda.gov/Drugs/
●参考Federal Register「Abbreviated New Drug Applications Submissions-Amendments To Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability」
https://www.federalregister.
また、これらについて、10/2付でFDA長官Scott Gottlieb氏が「Reducing the Hurdles for Complex Generic Drug Development」と題して、
https://blogs.fda.gov/
なお、今回のANDA関係のガイダンス等の発出に伴い、10/2
合せてお読み頂ければ、理解が深まるものと思います。
http://raps.org/Regulatory-
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