Fast track is a designation by the United StatesFood and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. 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 attempt to make a decision within sixty days.
Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need.
Serious condition: determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will affect 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.
Unmet medical need: gor a drug to address an unmet medical need, the drug may be developed as a treatment or preventative measure for a disease that does not have a current therapy. The type of information necessary to demonstrate unmet medical need varies with the stage of drug development: early in development, nonclinical data, mechanistic rationale, or pharmacologic data will suffice; later in development, clinical data should be utilized. If there are existing therapies, a fast track eligible 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 available treatment
Addressing an expected public health need.
Incentives
A drug that receives a fast track designation is eligible for some or all of the following:[3]
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
Accelerated approval or priority review if the requisite criteria are met. Accelerated approval is meant for drugs that demonstrate an effect on a surrogate, or intermediate endpoint reasonably likely to predict clinical benefit. Priority review shortens the FDA review process for a new drug from ten months to six months, and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy. A fast track application is automatically considered for both of these designations.
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
An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency's procedures for internal review or dispute resolution if necessary.
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.
^Inc, Immunomedics (5 January 2015). "Immunomedics Awarded Fast Track Designation by FDA for Sacituzumab Govitecan (IMMU-132) for Triple-Negative Breast Cancer Therapy". GlobeNewswire News Room. {{cite web}}: |last= has generic name (help)
^Commissioner, Office of the (3 November 2018). "Fast Track". FDA – via www.fda.gov.
Reichert JM, Rochon SL, Zhang BD (November 2008). "A decade of the Fast Track programme". Nat Rev Drug Discov. 7 (11): 885–6. doi:10.1038/nrd2733. PMID 18948998. S2CID 26150602.
External links
"Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review". For Patients and Patient Advocates. United States Food and Drug Administration. 15 June 2019.
fast, track, this, article, needs, additional, citations, verification, please, help, improve, this, article, adding, citations, reliable, sources, unsourced, material, challenged, removed, find, sources, fast, track, news, newspapers, books, scholar, jstor, j. This article needs additional citations for verification Please help improve this article by adding citations to reliable sources Unsourced material may be challenged and removed Find sources Fast track FDA news newspapers books scholar JSTOR July 2022 Learn how and when to remove this template message Fast track is a designation by the United States Food and Drug Administration FDA of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life threatening condition and fill an unmet medical need 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 attempt to make a decision within sixty days Contents 1 Purpose 2 Requirements 3 Incentives 4 See also 5 References 6 External linksPurpose EditFast track is one of fiveFDA approaches to make new drugs available as rapidly as possible 1 the others are priority review breakthrough therapy accelerated approval and regenerative medicine advanced therapy Fast track was introduced by the FDA Modernization Act of 1997 2 Requirements EditFast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life threatening disease and address an unmet medical need Serious condition determining whether a disease is serious is a matter of judgment but generally is based on whether the drug will affect 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 Unmet medical need gor a drug to address an unmet medical need the drug may be developed as a treatment or preventative measure for a disease that does not have a current therapy The type of information necessary to demonstrate unmet medical need varies with the stage of drug development early in development nonclinical data mechanistic rationale or pharmacologic data will suffice later in development clinical data should be utilized If there are existing therapies a fast track eligible 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 available treatment Addressing an expected public health need Incentives EditA drug that receives a fast track designation is eligible for some or all of the following 3 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 Accelerated approval or priority review if the requisite criteria are met Accelerated approval is meant for drugs that demonstrate an effect on a surrogate or intermediate endpoint reasonably likely to predict clinical benefit Priority review shortens the FDA review process for a new drug from ten months to six months and is appropriate for drugs that demonstrate significant improvements in both safety and effectiveness of an existing therapy A fast track application is automatically considered for both of these designations 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 FDAAn FDA decision not to grant fast track status or any other general dispute may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research The drug sponsor can subsequently utilize the Agency s procedures for internal review or dispute resolution if necessary 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 See also EditOrphan drug a similar FDA designationReferences Edit Fast Track Breakthrough Therapy Accelerated Approval Priority Review 1 Inc Immunomedics 5 January 2015 Immunomedics Awarded Fast Track Designation by FDA for Sacituzumab Govitecan IMMU 132 for Triple Negative Breast Cancer Therapy GlobeNewswire News Room a href Template Cite web html title Template Cite web cite web a last has generic name help Commissioner Office of the 3 November 2018 Fast Track FDA via www fda gov Reichert JM Rochon SL Zhang BD November 2008 A decade of the Fast Track programme Nat Rev Drug Discov 7 11 885 6 doi 10 1038 nrd2733 PMID 18948998 S2CID 26150602 External links Edit Fast Track Breakthrough Therapy Accelerated Approval and Priority Review For Patients and Patient Advocates United States Food and Drug Administration 15 June 2019 U S Dept of HHS FDA CDER and CBER Guidance for Industry Expedited Programs for Serious Conditions Drugs and Biologics CENTER FOR DRUG EVALUATION AND RESEARCH at 9 June 2013 available at https www fda gov downloads Drugs GuidanceComplianceRegulatoryInformation Guidances UCM358301 pdf Henninger Daniel 2002 Drug Lag In David R Henderson ed Concise Encyclopedia of Economics 1st ed Library of Economics and Liberty OCLC 317650570 50016270 163149563 Fast track approvals FDA Retrieved from https en wikipedia org w index php title Fast track FDA amp oldid 1134799325, wikipedia, wiki, book, books, library,
