Over the years, the FDA has offered programs to facilitate and expedite drug development and review of new drugs, and drug developers must meet certain criteria to be eligible for these programs. Fast track designation provides actions to expedite development and review, most notably the rolling submission and review.

Understanding Fast Track designation

The Food and Drug Administration (FDA) uses diverse regulatory approaches to enhance and expedite drug development and review. These approaches enable increased flexibility, efficiency, and interactions between regulators and drug developers to balance the somewhat conflicting precedents of speed and safety in drug approvals. In 2022, 12 of the novel drugs that was approved had Fast Track status.

Fast Track designation was initially introduced by the FDA Modernization Act of 1997 and later amended in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), becoming the FDA’s third expedited review program after Priority Review and Accelerated Approval. The FDA created the Fast Track program in 1992 to speed drug development to treat life-threatening diseases like HIV and cancer.

Fast Track Designation can be granted based on preliminary data, such as activity in a nonclinical model or pharmacological data, or a mechanistic rationale, enabling a low evidentiary hurdle. Fast Track speeds development and review of new drug and biological products by increasing the level of communication between FDA and drug developers and by enabling them to review portions of a drug application on a rolling basis.

Fast Track Qualifying Criteria

In order to be eligible for Fast Track designation, the proposed drug should be intended to treat a serious condition and nonclinical or clinical data must demonstrate the potential to address unmet medical need.

A Fast Track drug must prove some advantage over available therapies, such as:

  • Superior effectiveness, effect on serious outcomes, or improved effect on serious outcomes.
  • Avoiding serious side effects of an available therapy.
  • Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome.
  • Decreasing clinically significant toxicity of an available therapy that is common and causes discontinuation of treatment.
  • Ability to address emerging or anticipated public health needs.

Several severe conditions are addressed by Fast Track and the decision whether a condition is serious depends on a variety of factors. The determination is made by how the drug will impact survival, and daily functioning, or the likelihood that - if left untreated - it will progress from a less severe condition to a more serious one. The most obvious examples of serious conditions are AIDS, Alzheimer's disease, heart failure, and cancer. Other serious diseases could be epilepsy, depression, and diabetes.

Fast Track has been seen as a relatively low-risk program with long-term benefits for the drug developing companies, as an addition to the regulatory advantages. The Fast Track designation carries value for the drug developing company, by saving time and trimming costs. During 2022, a total of 291 requests for Fast Track designation was filed and 171 was granted.  

Submitting a Request

To be eligible for Fast Track, an applicant must submit a designation request and supporting documentation for the product and its intended use. A request is usually submitted to the Investigational New Drug (IND) and can occur at any time during the drug development process. Fast Track designation can be requested as early as the IND and the sweet spot is no later than the pre-NDA (or pre-BLA) meeting. The FDA will review and decide within 60 days of receiving the request whether the drug meets the criteria. 

A drug that receives Fast Track designation will benefit of some or all the following: 

  • More frequent meetings with the FDA to discuss the drug's development plan and ensure the collection of appropriate data needed to support drug approval.
  • More frequent written correspondence from the 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 existing therapy. A fast-track application is automatically considered for both designations.
  • Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by the 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.

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.

The FDA requires sponsors of drugs with Fast Track approval to follow up on confirmatory trials after the drug is on market.


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 and is performed by increasing the level of communication and rolling review. Drug developers can use this program to get early feedback on their submission and avoid unwanted surprises later on.

Is your product a potential candidate for an expedited program? At NDA, we can support you with a tailored strategy aiming to carry your product throughout the review and approval pathway at any speed. Contact us by using the form below.


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