Glossary

CBE 30

Similar to Changes Being Effected (CBE). A filing with the FDA to gain approval of a moderate change, i.e., a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product. FDA has 30 days to respond prior to implementation of the change. If filer receives no word from FDA in 30 days, it is assumed that the change was approved. See also Changes Being Effected and Prior Approval Supplement.