FDA SRP
The Safety Reporting Portal. The Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the Food & Drug Administration (FDA) ... ,2024年4月1日 — To submit via SRP, you must first establish an SRP account. A Gateway partner (i.e., a company that submits ICSRs electronically via the ESG) ... ,2022年9月6日 — • SRP portal features allows for browsing, selecting, and attaching documents to an ICSR. – Follow instructions in SRP to submit attachments ... ,2023年3月20日 — SRP-9001 是用於治療杜氏肌肉萎縮症（Duchenne muscular dystrophy，DMD）的研究型基因療法，這是一種罕見的神經肌肉疾病，由於X 染色體上DMD基因異常，某 ... ,2024年2月16日 — The FDA has accepted Sarepta Therapeutics' efficacy supplement for gene therapy SRP-9001, granting it a priority review for the treatment of ... ,由 DM Rind 著作 · 被引用 2 次 — After FDA leadership strongly encouraged flexibility, the FDA granted SRP-9001 accelerated approval in June 2023 (under the brand name ... ,2024年6月20日 — Elevidy's original approval in 2023 was based upon data from the phase 1/2 SRP-9001-101 (NCT03375164) study, the phase 2 SRP-9001-102 study, and ... ,ELEVIDYS has been evaluated in four clinical studies: SRP-9001-101, SRP-9001-102, SRP-9001-103 (ENDEAVOR) and SRP-9001-301 (EMBARK). Accelerated approval of ... ,2023年3月20日 — 不過事實是，FDA 宣布將在5 月29 日決定藥症是否給予的日期之前召開SRP-9001研究基因治療諮詢委員會會議。這代表有沒有安全問題，還沒有一個定數，這也 ... ,2023年11月27日 — This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA's Center for Biologics ...
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 FDA SRP 相關參考資料
Safety Reporting Portal
The Safety Reporting Portal. The Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the Food & Drug Administration (FDA) ... https://www.safetyreporting.hh FDA Adverse Event Reporting System (FAERS) Electronic ...
2024年4月1日 — To submit via SRP, you must first establish an SRP account. A Gateway partner (i.e., a company that submits ICSRs electronically via the ESG) ... https://www.fda.gov Safety Reporting Portal (SRP) Registration and Adverse ...
2022年9月6日 — • SRP portal features allows for browsing, selecting, and attaching documents to an ICSR. – Follow instructions in SRP to submit attachments ... https://www.fda.gov 核准前踩剎車！FDA 針對杜氏肌肉萎縮症首支基因轉移療法 ...
2023年3月20日 — SRP-9001 是用於治療杜氏肌肉萎縮症（Duchenne muscular dystrophy，DMD）的研究型基因療法，這是一種罕見的神經肌肉疾病，由於X 染色體上DMD基因異常，某 ... https://geneonline.news FDA Grants Priority Review to Efficacy Supplement for ...
2024年2月16日 — The FDA has accepted Sarepta Therapeutics' efficacy supplement for gene therapy SRP-9001, granting it a priority review for the treatment of ... https://www.neurologylive.com The FDA and Gene Therapy for Duchenne Muscular ...
由 DM Rind 著作 · 被引用 2 次 — After FDA leadership strongly encouraged flexibility, the FDA granted SRP-9001 accelerated approval in June 2023 (under the brand name ... https://jamanetwork.com FDA Approves Sarepta's DMD Gene Therapy Elevidys for ...
2024年6月20日 — Elevidy's original approval in 2023 was based upon data from the phase 1/2 SRP-9001-101 (NCT03375164) study, the phase 2 SRP-9001-102 study, and ... https://www.cgtlive.com Sarepta Therapeutics Announces U.S. FDA Acceptance of an ...
ELEVIDYS has been evaluated in four clinical studies: SRP-9001-101, SRP-9001-102, SRP-9001-103 (ENDEAVOR) and SRP-9001-301 (EMBARK). Accelerated approval of ... https://investorrelations.sare 《生技投資》Sarepta 之前表示治療杜氏肌肉萎縮症SRP-9001 ...
2023年3月20日 — 不過事實是，FDA 宣布將在5 月29 日決定藥症是否給予的日期之前召開SRP-9001研究基因治療諮詢委員會會議。這代表有沒有安全問題，還沒有一個定數，這也 ... http://www.genetinfo.com Voluntary Consensus Standards Recognition Program for ...
2023年11月27日 — This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA's Center for Biologics ... https://www.fda.gov |