Maintaining Your IND

Once an IND is in effect, the Sponsor-Investigator is responsible for amending the IND information to ensure that the protocol accurately reflects the clinical investigation. Sponsor-Investigators are expected to submit protocol amendments for new protocols or changes to existing protocols before implementing changes.

IND Sponsor-Investigators are required to notify FDA in a written safety report of:

1) any adverse experience associated with the use of the drug that is both serious and unexpected; or

2) any findings from tests in laboratory animals that suggest a significant risk for human subjects including reports of mutagenicity, teratogenicity, and carcinogenicity.

IND Sponsor-Investigators are expected to submit brief annual reports of the progress of the investigations conducted under their IND application within 60 days of the anniversary date that the application went into effect.