Reduced stability database may be acceptable for new formulations of approved drugs.
This article was originally published in The Tan Sheet
Executive Summary
STABILITY DATA REDUCED INFOBASE ACCEPTABLE FOR NEW FORMULATIONS, drug combinations and dosage forms of approved drug products under certain circumstances, FDA indicates in a June 8 draft guidance, "Stability Testing of Drug Substances and Drug Products." Generally, for new combos or formulations of already marketed products, sponsors should follow International Conference on Harmonization guidance Q1A for stability testing of new drug substances. The ICH guidance requires six months of accelerated stability data and 12 months of long-term data on three batches, the draft guidance states.