Rac Sample Test (100 Questions) With 100% Correct Verified Answers

An NDA holder wants to extend the drug product shelf life from two to three years. What is the best course of action to pursue? A. Present three years of real-time stability data on three consecutive batches following an approved stability protocol in the NDA Annual Report B. Present 18 months of accelerated stability data on three consecutive batches in the NDA Annual Report C. Present three years of real-time stability data on three consecutive batches in an NDA Changes Being Effected in 30-Days supplement D. Present 18 months of accelerated stability data on three consecutive batches in a NDA Changes Being Effected in 0-Days supplement {Ans: A. Present three years of real-time stability data on three consecutive batches following an approved stability protocol in the NDA Annual Report Question Feedback: §314.70(d)(2)(vi), Data from stability studies should be provided on at least three consecutive batches of the drug product. An extension of an expiration dating period based on full shelf life data on production batches obtained under a protocol approved in the application. In the absence of an approved/agreed stability protocol with FDA, if the sponsor chose to provide real time stability data on three batches, the change should