There are many pitfalls that come with preparing an Investigational New Drug application for FDA submission. Luckily, there are also plenty of ways to avoid them. But the most important strategy? It all comes down to one thing: Always remember to keep your audience (the FDA reviewers) in mind as you write.
These five actionable steps can help ensure your next IND is a successful one:
1. Organize the document in a way that is easy to review and understand
Using a Target Product Profile (TPP) provides your IND with a clear goal and organizational structure. While specifying the proposed draft product label may seem like jumping the gun, it allows you to align your strategy and goals before working backwards. This helps lay down a clear, complete path from beginning to end, with each section building upon the last with overlapping support. The result? A cohesive and compelling application.
Likewise, the writing itself should be just as cohesive. In cases where multiple vendors contribute to IND submission, there will likely be noticeable differences in writing styles between sections. Make sure you have a skilled editor craft a consistent style and format for easy reading.
As a living document, your IND will likely continue to evolve until the corresponding New Drug Application (NDA) is approved. Paying close attention to the details at this early stage can help make the approval process much smoother.
2. Document rationales for conclusions and include supporting data
Your IND should provide the FDA reviewers with clear data and explanations for results. Make sure these results match your protocol, and avoid irrelevant information that can reduce the impact of your text. Also, check that your key messages support the importance of your submission. All of this should be done in a concise, well-thought-out manner.
3. Be brief
“Brevity is the soul of wit” is something that is often forgotten in medical writing. When writing your IND, stay focused and use simple words rather than jargon. Reviewers may be familiar with the basics of your therapeutic area but are unlikely to know specific details. When using abbreviations and technical terms, be sure to accurately define them. Where possible, incorporate figures and tables to replace dry, lengthy paragraphs.
4. Use the FDA guidance
Use all available FDA guidelines as a checklist to make sure your IND covers everything required by the FDA. If you need further clarification, you can also request a pre-IND meeting with representatives from the FDA, who can help give you individualized advice for preparing your application. This will give you an opportunity to ask questions before the submission clock starts ticking. Taking advantage of this opportunity can help improve your submission, increasing the chances of a fast turnaround and approval.
However, be prepared before asking for a pre-IND meeting. After all, this meeting will be your chance to give a good impression.
5. Get support from an experienced CRO
The right contract research organization (CRO) is a valuable asset for IND submission. Skills in regards to teamwork and resource sharing can help you produce higher quality work. Experienced CROs also bring deep understanding of the IND submission process and up-to-date FDA guidances to the table. They are also likely to have experience meeting with FDA personnel and can help with every step of the clinical development process.
For more information on solutions for common IND submission problems, be sure to download our full white paper, Preparing an IND: Common Errors and Solutions. If you’re liking the blogposts here, you can sign up for more Premier Perspectives to keep up with our latest info.