21 C.F.R. § 822.14 May I reference information previously submitted instead of submitting it again?
Title 21 - Food and Drugs
Yes, you may reference information that you have submitted in premarket submissions as well as other postmarket surveillance submissions. You must specify the information to be incorporated and the document number and pages where the information is located.
Title 21: Food and Drugs
PART 822—POSTMARKET SURVEILLANCE
Subpart C—Postmarket Surveillance Plan
§ 822.14 May I reference information previously submitted instead of submitting it again?
