Trust Snow Regulatory Affairs Consulting to guide you through every step of the Fast Track designation process, maximizing your chances of success.

Fast Track

The FDA Fast Track designation is a process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. 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.

Fast Track Criteria To Consider:

Serious Condition

A disease or condition is considered serious if it significantly impacts day-to-day functioning due to associated morbidity. While temporary and self-resolving morbidity may not meet this criterion, persistent or recurrent morbidity does, even if it is reversible. All conditions that are defined as life-threatening are also classified as serious.

AND…Filling an Unmet Medical Need

Filling an unmet medical need refers to providing a therapy where no satisfactory alternative therapy exists, or offering a treatment that is significantly better than existing options in terms of effectiveness, safety, or tolerability. Nonclinical or clinical data need to demonstrate the potential to address unmet medical need.

OR- A Drug that has been designated as a qualified infectious disease product

If there are existing treatments, the new drug must demonstrate some advantage over them, such as:

• Showing Superior/Greater effectiveness, impact on serious outcomes, or improved effect on serious outcomes
• Avoiding serious side effects associated with the current therapy
• Lowering/Decreasing clinically significant toxicity of the current therapy that frequently leads to treatment discontinuation
• Capability/Ability to meet emerging or anticipated public health needs

Key benefits of Fast Track Designation

• Accelerated Development and Review: Drugs that receive Fast Track designation are eligible for more frequent meetings and communications with the FDA to discuss the drug’s development plan and ensure the collection of appropriate data needed to support drug approval.
• Rolling Review: The drug’s sponsor can submit completed sections of the New Drug Application (NDA) or Biologics License Application (BLA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.
• Priority Review: If supported by clinical data at the time of NDA or BLA submission, drugs with Fast Track designation may be eligible for priority review, reducing the FDA review period from the standard ten months to six months.
• Eligibility for Accelerated Approval and Breakthrough Therapy Designation: Fast Track designation can also make the drug eligible for other FDA programs that expedite development and review, such as accelerated approval and breakthrough therapy designation.

Overall, the FDA Fast Track designation aims to make important new drugs available to patients more quickly by facilitating earlier and more frequent interactions between the FDA and drug developers, ensuring that key data is collected efficiently, and enabling faster review times.

When to Submit Request – Time Frames for Fast Track Designation

• Before the New Drug Application (NDA) or Biologics License Application (BLA): Ideally, the request should be submitted no later than the end of Phase 2 meetings, but it can be submitted at any time during the drug development process.
• With Initial Investigational New Drug (IND) Submission: A Fast Track designation request can be included with the initial IND application.

Once a request is submitted, the FDA has 60 days to review the request and make a decision.

Benefits on working with Snow Regulatory Affairs Consulting on Your Fast Track Designation Process:

As a consultant guiding a drug manufacturer through the FDA Fast Track Designation process, here is a summary of the benefits of obtaining guidance from Snow Regulatory Affairs Consulting:

1. Expertise in Regulatory Requirements:

   Navigating the FDA Fast Track Designation process requires a thorough understanding of complex regulatory requirements. Snow Regulatory Affairs Consulting brings in-depth knowledge of these regulations, ensuring that all necessary criteria are met and reducing the risk of delays or rejections.

2. Streamlined Application Process:

   Snow Regulatory Affairs Consulting can streamline the application process by helping your team prepare and organize the required documentation efficiently. This includes compiling compelling evidence that your drug meets the criteria for Fast Track Designation, thereby increasing the likelihood of a successful application.

3. Enhanced Communication with the FDA:

   Frequent and effective communication with the FDA is critical during the Fast Track Designation process. Snow Regulatory Affairs Consulting can facilitate these interactions, ensuring that your team receives timely feedback and guidance from the FDA, which can significantly accelerate the development and review process.

4. Strategic Planning and Development:

   Snow Regulatory Affairs Consulting can assist in developing a strategic plan that aligns with FDA expectations. This includes designing clinical trials, selecting appropriate endpoints, and ensuring that the data collected supports both the Fast Track Designation application and subsequent steps in the drug approval process.

5. Risk Mitigation:

   By anticipating potential challenges and regulatory hurdles, Snow Regulatory Affairs Consulting can help mitigate risks associated with the Fast Track Designation process. Our expertise allows for proactive problem-solving, reducing the likelihood of setbacks that could delay your drug’s development and approval.

6. Access to Additional Expedited Programs:

   With our knowledge of FDA programs, Snow Regulatory Affairs Consulting can identify opportunities for your drug to qualify for other expedited pathways, such as Breakthrough Therapy Designation or Accelerated Approval. This can further shorten the time to market and enhance the drug’s overall development strategy.

7. Optimized Resource Allocation:

   Snow Regulatory Affairs Consulting can help your team allocate resources more effectively by focusing efforts on the most critical aspects of the Fast Track Designation process. This ensures that time and budget are used efficiently, maximizing the return on investment.

8. Competitive Advantage:

   Successfully obtaining Fast Track Designation can provide a significant competitive advantage by allowing your drug to reach the market more quickly. Snow Regulatory Affairs Consulting increases the likelihood of achieving this designation, positioning your product favorably within the industry.

We look forward to discussing your needs with you!