What is an IND application?

An IND application is a request to the FDA to begin clinical trials involving a new drug or biologic, requiring comprehensive preclinical data and clinical study designs.

How long does the FDA take to review an IND application?

FDA review typically takes 30 days, during which they assess the safety and ethical considerations of the proposed studies.

Can I make changes to my IND application later?

Yes, you can amend your IND application; however, significant changes may require notification or approval from the FDA before the changes can take effect.