How many days does the FDA have to approve or disapprove an Investigational New Drug Application (INDA)?

The time frame for the FDA to approve or disapprove an Investigational New Drug Application (INDA) is indeed 30 days. This period begins after the submission of the application, during which the FDA reviews the clinical trial's safety data and proposed study protocols. If the FDA does not take action within this 30-day period, the sponsor may proceed with their clinical trials. This critical review period is designed to ensure that the proposed studies do not pose undue risk to participants, reflecting the FDA's commitment to safeguarding public health while also allowing research to progress. Understanding this timeframe is essential for those involved in pharmaceutical development and compliance with regulatory obligations.