Presubmission Conference Agreement Sample Contracts
Food and Drug Administration, HHS § 514.8Presubmission Conference Agreement • January 11th, 2020
requires 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 • September 29th, 2020
whole, the agreement and such modi- fication is documented and provided to the potential applicant as described in paragraph (f)(1) of this section; or
ContractPresubmission Conference Agreement • January 11th, 2020
requires 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.
Food and Drug Administration, HHS § 514.8Presubmission Conference Agreement • September 29th, 2020
whole, the agreement and such modi- fication is documented and provided to the potential applicant as described in paragraph (f)(1) of this section; or