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Succeeding with the FDA: Answers to Seven Common Questions About IND Submissions

Submission of an Investigational New Drug Application (IND) is a milestone in new drug development, marking the transition from bench research to clinical studies in human participants. Successful IND submission requires careful planning and strict compliance with regulatory requirements, which can be especially challenging for first-time applicants. In this article, we offer answers to seven questions we commonly receive about developing a timely and well-structured IND submission.

We’ll answer questions like:

  • What is the structure of the Common Technical Document?
  • What is the purpose and value of a pre-IND meeting?
  • Can foreign data be included in the IND?
  • What are the requirements for manufacturing in the IND?
  • What is the regulatory timeline for U.S. IND submissions?

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