2005D-0122 Guidance for Industry on Exploratory IND Studies
FDA Comment Number : EC14
Submitter : Mr. Gary Klee Date & Time: 07/15/2005 01:07:15
Organization : Organichem Corporation
Category : Drug Industry
Issue Areas/Comments
Under the Cemistry, Manufacturing, and Controls Information of the draft guidance, it states that the Agency is in the process of developing guidance explaining the stepwise approach to meeting current GMP regulations. Can you provide a date as to when this guidance will be available. For the API (drug substance), will this guidance be consistent with the requirements of ICH Q7A under the "APIs for use in Clinical Trials", especially in regard to where GMP starts?

In direct discussions with the FDA contact on the draft guidance for Exploratory IND Studies, we have been told that the API used for these studies does not need to be made under GMPs. Can you comment on this?

Thank you.