FDA Publishes Draft Guideline for Supplements to NDA's, ANDA's, or AADA's for Nonsterile Drug Products

Summary

The FDA is publishing a draft guideline to help distinguish between manufacturing changes that require prior approval through a supplement to an approved NDA, ANDA, or AADA, and those that can be made without prior approval. The guideline covers changes in equipment, reprocessing of drug products, and facility changes.