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.