Investigational New Drug Applications: Five Solutions To Common Problems

There are many pitfalls that come with preparing an Investigational New Drug (IND) application for FDA submission, but with the right plan – and the right partner – there are also plenty of ways to avoid them.

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 parties contribute to an 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.

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