ContractPresubmission Conference Agreement • January 11th, 2020
Contract Type FiledJanuary 11th, 2020requires one field study to be con- ducted at multiple locations, FDA will provide justification for requiring mul- tiple locations verbally during the pre- submission conference and in writing as part of the memorandum of con- ference.
ContractPresubmission Conference Agreement • October 17th, 2014
Contract Type FiledOctober 17th, 2014requires one field study to be con- ducted at multiple locations, FDA will provide justification for requiring mul- tiple locations verbally during the pre- submission conference and in writing as part of the memorandum of con- ference.