“fast track designation” 在网络上搜到是“快速跟踪身份”的意思，有的也翻译成“绿色通道”，但是具体的意思还是不太理解。是指FDA先将该药摆到首要的位置来审核的意思吗？还是有一些手续可以省去不用办？
E.g. FDA has granted fast track designation to the Company's unique next-generation antifolate PDX (pralatrexate) for the treatment of patients with T-cell lymphoma.
FDA为了协助针对那些没有有效治疗手段的危急疾病(癌症,AIDS等)的药物尽快上市,采取了加速评审。1997年出了个法规《食品药品现代化管理法》（FOOD AND DRUG MODERNIZATION ACT OF 1997），该法建立了独立的称为"fast track"的法规条款（一般翻译为“快径”）。倘若主办者认为申请的某新药符合FDA“fast track” 要求，可以在临床研究（IND）中就可以向FDA提出申请快径资格（Request for Fast Track Designation),上面 楼主引的FDA has granted fast track designation 那句话就是表明 FDA准许了公司的“快径资格”
想问一下，在FDA官网上哪个位置可以查某个在研药是不是被批准了Fast Track designation啊？？急。。。谢谢
指南和程序在此·
Fast Track Designation Request Performance
The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.
To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use. FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met. This report illustrates CBER's performance in reviewing and deciding on these requests.
Details on the FDA fast track program, including Section 112 of FDAMA and the proposed and final rules in the Federal Register can be found in the Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review - 11/18/981; Appendix 2; Appendix 3 - (CDER MAPP 6020.3); CBER SOPP 8405; Appendix 4.
CBER Fast Track Designation Request Performance Report
All Requests Received
(March 1, 1998 through December 31, 2011)
E.g. FDA has granted fast track designation to the Company's unique next-generation antifolate PDX (pralatrexate) for the treatment of patients with T-cell lymphoma.
FDA为了协助针对那些没有有效治疗手段的危急疾病(癌症,AIDS等)的药物尽快上市,采取了加速评审。1997年出了个法规《食品药品现代化管理法》（FOOD AND DRUG MODERNIZATION ACT OF 1997），该法建立了独立的称为"fast track"的法规条款（一般翻译为“快径”）。倘若主办者认为申请的某新药符合FDA“fast track” 要求，可以在临床研究（IND）中就可以向FDA提出申请快径资格（Request for Fast Track Designation),上面 楼主引的FDA has granted fast track designation 那句话就是表明 FDA准许了公司的“快径资格”
想问一下，在FDA官网上哪个位置可以查某个在研药是不是被批准了Fast Track designation啊？？急。。。谢谢
指南和程序在此·
Fast Track Designation Request Performance
The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.
To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use. FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met. This report illustrates CBER's performance in reviewing and deciding on these requests.
Details on the FDA fast track program, including Section 112 of FDAMA and the proposed and final rules in the Federal Register can be found in the Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review - 11/18/981; Appendix 2; Appendix 3 - (CDER MAPP 6020.3); CBER SOPP 8405; Appendix 4.
CBER Fast Track Designation Request Performance Report
All Requests Received
(March 1, 1998 through December 31, 2011)
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Number Submitted 名单在此 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/FastTrackApprovalReports/ucm082380.htm 汇总数据在此 Fast Track Approval Reports http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/FastTrackApprovalReports/default.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/FastTrackApprovalReports/default.htm http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm Fast track 和 Priority review 有什么区别或者联系么？ FDA答复如下 Fast Track Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious diseases. However, diseases such as epilepsy, depression and diabetes are also considered to be serious diseases. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy. Any drug being developed to treat or prevent a disease with no current therapy obviously is directed at an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as: Showing superior effectiveness Avoiding serious side effects of an available treatment Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome Decreasing a clinically significant toxicity of an accepted treatment A drug that receives Fast Track designation is eligible for some or all of the following: More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval More frequent written correspondence from FDA about such things as the design of the proposed clinical trials Eligibility for Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA, and Dispute resolution if the drug company is not satisfied with an FDA decision not to grant Fast Track status. In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious disease. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. Accelerated Approval When studying a new drug, it can take a long time - sometimes many years - to learn whether a drug actually provides real improvement for patients – such as living longer or feeling better. This real improvement is known as a “clinical outcome.” Mindful of the fact that obtaining data on clinical outcomes can take a long time, in 1992 FDA instituted the Accelerated Approval regulation, allowing earlier approval of drugs to treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker - a laboratory measurement, or physical sign - that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Approval of a drug based on such endpoints is given on the condition that post marketing clinical trials verify the anticipated clinical benefit. The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for thatendpoint. 3 1 2 3 下一页 尾页 上一篇:关于子母公司药品转让问题
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