Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

This is the first in a three-part series on planning for a successful investigational new drug (IND) application published by Pharmaceutical Online.

If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity for a pre-IND.

The pre-IND meeting represents a critical point in the regulatory process and remains one of the near-guaranteed opportunities to obtain valuable FDA feedback, while establishing a strong relationship with the agency. Though it requires a couple of months from the time you submit a meeting request to the time feedback is obtained, the pre-IND meeting has the potential to save time in the long run and can really shape the overall strategy for drug development for the compound under study.

If you’re wondering how adding a pre-IND meeting could possibly reduce time to market, you’re not alone. The FDA has actually addressed this question on their website, indicating that time can be reduced by the following

• Identifying and avoiding unnecessary studies
• Allowing early interactions/negotiations with FDA
• Clearly defining endpoints and goals of the development program
• Minimizing costs
• Obtaining regulatory insight
• Providing opportunity for creative exchange of ideas
• Potentially minimizing potential for clinical hold
• Gaining FDA support for a proposed strategy
• Ensuring that necessary studies are designed to provide useful information

As mentioned, the pre-IND feedback can help identify studies to support the initiation of clinical trials and can provide insight as to whether development can be enhanced by methods/programs such as orphan drug designation, fast track designation, accelerated approval, Animal Efficacy Rule, or even breakthrough therapy designation.

Please head to Pharmaceutical Online to read the full article.