Regulatory Affairs Certification (RAC) Practice Exam

Senior management at your company asked you to develop a justification for fast track status for an investigational new drug for epilepsy. Which of the following would be an appropriate justification for FDA granting fast track status?

1. Preliminary evidence of effectiveness was seen in the principal controlled trials intended to provide evidence of effectiveness.

2. Epilepsy is considered by FDA to be a serious disease.

3. Pharmacokinetic profile of the new drug indicates less potential for toxic drug-drug interactions with other anticonvulsant medications.

4. Answers A, B, and C.

The correct answer is: Answers A, B, and C.

To justify a request for fast track status for an investigational new drug for epilepsy, it is essential to consider factors that align with the FDA's criteria for this designation. Fast track status is intended for drugs that treat serious conditions and fill an unmet medical need. The presence of preliminary evidence of effectiveness from controlled trials indicates that the drug has shown potential benefits in treating epilepsy. This is crucial because fast track status is granted in part based on the drug's ability to demonstrate an early promise of effectiveness, thus accelerating its development and review process. Moreover, epilepsy is classified by the FDA as a serious disease, which inherently supports the request for fast track status. The seriousness of the condition underscores the need for timely access to therapeutics that can improve patient outcomes, making it a key component of the justification. Lastly, demonstrating a favorable pharmacokinetic profile that suggests less potential for toxic drug-drug interactions with existing anticonvulsant medications is also significant. This aspect not only addresses safety considerations, which are paramount in the development of drug therapies but also enhances the drug's therapeutic appeal, as it suggests a greater likelihood of being well-tolerated by patients already on other treatments. By incorporating all these factors—preliminary effectiveness, the seriousness of the disease