Fast Track | FDA
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`Fast Track
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`Fast track is a process designed to facilitate the development, and expedite the review
`of drugs to treat serious conditions 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 conditions.
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`Determining whether a condition 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 condition, 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 conditions. However, diseases such as epilepsy,
`depression and diabetes are also considered to be serious conditions.
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`Filling an unmet medical need is defined as providing a therapy where none exists or
`providing a therapy which may be potentially better than available therapy.
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`Any drug being developed to treat or prevent a condition with no current therapy
`obviously is directed at an unmet need. If there are available therapies, a fast track
`drug must show some advantage over available therapy, such as:
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`• Showing superior effectiveness, effect on serious outcomes or improved effect on
`serious outcomes
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`• Avoiding serious side effects of an available therapy
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`• Improving the diagnosis of a serious condition where early diagnosis results in
`an improved outcome
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`• Decreasing a clinical significant toxicity of an available therapy that is common
`and causes discontinuation of treatment
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`• Ability to address emerging or anticipated public health need
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`A drug that receives Fast Track designation is eligible for some or all of the following:
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`• More frequent meetings with FDA to discuss the drug's development plan and
`ensure collection of appropriate data needed to support drug approval
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`• More frequent written communication from FDA about such things as the design
`of the proposed clinical trials and use of biomarkers
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`https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priori...
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`12/19/2019
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`Opiant Exhibit 2181
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 1
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`Fast Track | FDA
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`• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are
`met
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`• Rolling Review, which means that a drug company can submit completed
`sections of its Biologic License Application (BLA) or New Drug Application
`(NDA) for review by FDA, rather than waiting until every section of the NDA is
`completed before the entire application can be reviewed. BLA or NDA review
`usually does not begin until the drug company has submitted the entire
`application to the FDA
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`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 condition.
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`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.
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`https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priori...
`
`12/19/2019
`
`Opiant Exhibit 2181
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 2
`
`