An investigational new drug application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug or biological (serums, vaccines, antitoxins, antigens, etc.) to humans. IND applications are the basis for approval of clinical trials by competent regulatory authorities within the United States. Investigational Medicinal Product Dossiers (IMPDs) are the equivalent in the European Union.
Strategies
- Using a Target Product Profile (TPP) provides your IND with a clear goal and organizational structure. Organize the document in a way that is easy to review and understand.
- The writing itself should be 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.
- IND should provide the FDA reviewers with clear data and explanations for results. Avoid irrelevant information that can reduce the impact of your text.
- Check that your key messages support the importance of your submission. All of this should be done in a concise, well-thought-out manner.
- Stay focused and use simple words rather than jargon when writing IND. When using abbreviations and technical terms, be sure to accurately define them.
Working with MedTrans dedicated team to prepare not only the initial trial applications, but also subsequent trial documentation (e.g. protocols, Informed Consent Forms, Investigator's Brochures, study reports, subject narratives, Risk Management Plans, Periodic Safety Update Reports, etc.) ensures consistency and continuity – making the overall writing process more efficient – and the conclusions much clearer. Contact us today to find out how our writing expertise can help you to prepare your IND applications.