NOCc and Guidance on Duration of Clinical Trials
Hello Jennifer. What are the implications of an NOCc on the use of extension studies in advertising? This refers to the "Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising."
Jennifer Carroll last edited by
In Guidance on Advertising for Drugs with Notice of Compliance with Conditions (Noc/c), point 3 states: “For NOC/c product advertising, studies and/or data which are not presented in the Terms of Market Authorization will not be accepted”. The referenced extension studies guidance would not supersede this restriction.
@jennifer-carroll Thank you.