Once an IND application is in effect, the sponsor of the application may amend the application as needed to ensure that the clinical investigations are conducted according to protocols included in the IND application. Sponsors are expected to submit protocol amendments for new protocols or changes to existing protocols before implementation of the respective changes. New studies may begin when the sponsor has submitted the change to FDA for its review and the new protocol or changes to the existing protocol have been approved by the Institutional Review Board (IRB) with the responsibility for review and approval of the studies. If the IND application sponsor desires FDA to comment on a submission, they should submit a request for such comment and the specific questions that FDA's response should address.
When several submissions with minor amendments are expected within a short period, sponsors are encouraged, to the extent feasible, to include all amendments in a single submission.
Any specific technical information referenced in an IND application amendment as already submitted to FDA in the original IND application is expected to be identified by name, reference number, volume, page number, and date of submission. The general types of protocol amendments are shown below.
For example, changes requiring an amendment to an IND application may include: