Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program

Summary

The Food and Drug Administration (FDA) is launching a pilot program to collect chemistry, manufacturing, and controls (CMC) information from pharmaceutical companies, with the goal of developing a guidance for industry on the new pharmaceutical quality assessment system. The program aims to provide participating companies with an opportunity to demonstrate their understanding of quality by design and to gather feedback from the public and industry.