*美國FDA 發布

Oct/15/2018旨在提高藥物開發過程的效率。
1.草案:Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment 
討論了在某些血癌的臨床試驗中使用MRD作為生物標誌物。FDA認為,可闡明如何最好地使用MRD作為腫瘤負荷的一般指標或評估復發的可能性。
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM623333.pdf

2.最終指引: Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease 建構法規框架對於找尋治療解決導致或促成疾病的分子層面變異(例如,基因療法)。包括提供藥物開發者在臨床試驗中納入具有罕見遺傳變異的患者,以及證明有效性所需的證據等。
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588884.pdf
 

*FDA為推動複雜性學名藥的開發以促進市場競爭和病患獲取藥品可近性之新努力,近日又宣布了一系列指引文件,這些文件將推動學名藥穿皮和局部遞送系統(TDS)的發展。包括:

1. Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM504157.pdf
 
2. Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM622672.pdf

3. 25 product-specific guidance documents.(Product-Specific Guidances for Generic Drug Development)
https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm
 
”Adaptive Designs for Clinical Trials of Drugs and Biologicals”(指引草案: 調整設計臨床試驗)此版取代之前的2010年版指引草案。

“調整設計臨床試驗”允許基於試驗中受試者累積之數據對試驗設計進行預期計劃性的修改(計畫書預先載明調整設計計畫)。 該指引說明了“調整設計臨床試驗”之設計、執行及結果報告的重要原則;提供建議有關FDA評估調整試驗臨床設計試驗結果所需的資訊類型,包括依賴電腦模擬設計的Bayesian adaptive 和復雜試驗。此指引也闡釋當試驗開始時尚無法獲得資料時,調整設計臨床試驗可以如何被允許。 https://www.fda.gov/downloads/drugs/guidances/ucm201790.pdf

 

* Sep/25/2018公告: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics

旨在與FDA 2014年另公告的指引 “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications” 一起閱讀,有詳細介紹了FDA評估實質相等性的方法。

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM404773.pdf

 

Aug/10/2018公告: "Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry"

指引草案,協助癌症藥物開發廠設計和開展首次人體臨床試驗(FIH),通過multiple expansion cohort設計加速臨床開發。提供了FDA關於適合此類加速計劃的藥物和生物製劑訊息,包括在此類研究性新藥(IND)申請中的信息,何時與FDA進行互動以及保護患者參加FIHexpansion cohort臨床實驗的保護措施.

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm616325.pdf

 

 

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