FDA's Fast Track Program

For Serious Conditions – Unmet Medical Needs 

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and fill an unmet medical need. Following are key details of the program. 

Definition of Serious Conditions 

Serious conditions, as defined by the FDA, are those that pose a significant impact on day-to-day functioning, survival, or the likelihood of progression to a more severe state if left untreated. Examples include cancer, AIDS, Alzheimer’s disease, and certain types of heart failure. 

Unmet Medical Need 

To qualify for the Fast Track program, a drug or biologic must address an unmet medical need. This could mean providing a therapy where none exists or offering a treatment that may be potentially better than currently available options. 

Benefits of Fast Track Designation 

Fast Track designation offers several benefits to sponsors, including: 

• More frequent meetings with the FDA to discuss the drug’s development plan and ensure the collection of appropriate data needed for approval. 
• More frequent written communication from the FDA regarding the design of proposed clinical trials and the use of biomarkers. 
• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met. 
• Rolling Review, allowing a drug company to submit completed sections of its New Drug Application (NDA) or Biologics License Application (BLA) for review by the FDA instead of waiting until the entire application is complete. 

Fast Track Designation Process 

Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. The FDA reviews the request and makes a decision within 60 days based on whether the drug fills an unmet medical need in a serious condition. 

Commitment to Early Communication 

Once a drug receives Fast Track designation, early and frequent communication between the FDA and the drug company is encouraged throughout the entire drug development and review process. This frequent communication helps resolve questions and issues quickly, often leading to earlier drug approval and access by patients. 

Summary 

Overall, the Fast Track program aims to expedite the development and review of drugs and biologics for serious conditions with unmet medical needs, ultimately accelerating patient access to potentially life-saving treatments. 

Links 

Read more about the FDA Fast Track Program.