"Requests for clinical trial approval should ordinarily be made in writing, however, in limited circumstances, such requests may be made orally and permission may be given orally by the Director. Oral requests and approvals must be promptly followed by written requests and written approvals".
This is the proceedure for the FDA.
You need to copy paste the three trials from the KEDEM website, so the FDA will know what you are refering to. A phone call is OK, but they will do nothing without a written letter. I think that you should write them first & then call later, so they can reference your letter while talking with you.
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