ANDA bulk supplier change for cGMP problems will not require in vivo study in most cases -- FDA.

Executive Summary

ANDA BULK SUPPLIER CHANGE FOR cGMP REASONS WILL NOT REQUIRE NEW IN VIVO STUDY to demonstrate bioequivalence with the previous supplier under a new policy established by FDA's Office of Generic Drugs. "Effective immediately, for unapproved applications OGD will allow substitution of an alternate source of the [new drug substance] based on assurance that the specifications and test data are essentially the same as those of the original source used in the exhibit batch (and bioequivalence study, if required) that would have been acceptable except for CGMP issues," a July 26 OGD memo states.