Once we submit the IND application, how the FDA reviews the application and what acknowledgment letter is given after the IND submission all will be discussed here.

IND is an application submitted to the FDA to conduct clinical investigations in humans, once the application is submitted to the FDA, the FDA will take 1 week to 10 days to send the acknowledgment letter. This acknowledgment letter aims to notify the applicant of the date of receipt of the application along with it, it contains below information

• IND Assigned number
• FDA contact
• Assigned FDA review division
• Along with the date of receipt it also says which date is considered as 30th day

Note: We have already discussed the importance of day 30, as after this date companies can start their studies, as the FDA has a 30-day review period.

How FDA reviews the application: The FDA takes 30 days to review the application, once received IND review starts when all the chemistry, pharmacology, statistical information, and medicinal information are reviewed, then safety review, if safety is acceptable review will be completed and study begins

Here is a flow chart of FDA – IND application review process