The US Food and Drug Administration (FDA) has clarified definitions and appropriate reporting of minor label changes for over-the-counter (OTC) drugs in draft guidance expected to reduce regulatory burden on both industry and FDA.
The draft guidance, issued 12 March, applies to nonprescription drug products approved through a new drug application (NDA) or abbreviated new drug application (ANDA). Per regulations, sponsors may make minor changes and distribute new packaging immediately to consumers, and then document updates in a summary in their next annual report, rather than applying for a label change.
“Minor changes include certain changes that have a minimal potential to have an adverse effect on the identity, strength, quality, purity or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product,” FDA explained in the guidance document, titled Annual reportable labeling changes for new drug applications and abbreviated new drug applications for nonprescription drug products…
