From the Research
The correct answer is C. 30 calendar days. After submitting an Investigational New Drug (IND) application to the FDA, sponsors must wait 30 calendar days before initiating any clinical research activities related to the investigational drug. This 30-day waiting period serves as a safety review period during which the FDA examines the application to ensure that research participants will not be exposed to unreasonable risks. During this time, the FDA may place a clinical hold on the study if they identify safety concerns. If the sponsor does not receive notification of a clinical hold within the 30-day period, they may proceed with the clinical investigation as outlined in their IND application. This waiting period is a critical component of Good Clinical Practice (GCP) and regulatory compliance in clinical research to protect human subjects, as stated in the study by 1.
Some key points to consider include:
- The FDA requires a 30-day waiting period after IND submission to review the application and ensure participant safety.
- The sponsor may proceed with the clinical investigation if no clinical hold is placed within the 30-day period.
- This waiting period is essential for protecting human subjects and ensuring compliance with regulatory requirements.
- The study by 1 provides guidance on the IND application process and the importance of the 30-day waiting period.
It's worth noting that the other studies provided, such as 2, 3, 4, and 5, do not directly address the question of the waiting period after IND submission and are therefore not relevant to this specific question. The most recent and highest quality study that addresses this question is 1, which provides clear guidance on the 30-day waiting period.