IND Submission

The IND submission process is fairly straightforward and requires the following items:

IND Investigational use of a marketed drug

• Cover letter
• IND application for marketed drugs
• FDA Form 1571¹
• FDA Form 1572²
• FDA Form 3674³
• Package insert for marketed drug used in study
• Protocol
• IND Sponsor CV

IND Investigational use of a drug that has not been approved

• Cover letter
• IND application for drug that has not been approved
• FDA Form 1571¹
• FDA Form 1572²
• FDA Form 3674³
• Investigator’s Brochure (if applicable)
• Protocol
• IND Sponsor CV

¹FDA Form 1571 (3/19)* https://www.fda.gov/media/116608/download;

¹instructions for completing 1571 (03/19)* https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=2ahUKEwjP6Ou035rpAhXpguAKHYQrACAQFjAAegQIARAB&url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F77596%2Fdownload&usg=AOvVaw2NU6Dlh9ULv3_YWsRoV7UG

²FDA Form 1572 (3/22)*  https://www.fda.gov/media/71816/download ; 

²Instructions for completing 1572 (7/13)*  https://www.fda.gov/media/79326/download ; FAQs for 1572 https://www.fda.gov/media/78830/download

³FDA Form 3674 (11/21)* https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwj2-9zAkKTzAhXwSTABHS2jCUsQFnoECAYQAQ&url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F134964%2Fdownload&usg=AOvVaw06ymVUEctwQjBjLK-ferqE

³Instructions for completing 3674 (7/17)* https://www.fda.gov/media/86100/download

*the FDA form links provided are current as of 8.2.2022. To ensure you are using the most current FDA Form, search the FDA website at www.fda.gov