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

Résumé

The Food and Drug Administration (FDA) is seeking pharmaceutical companies to volunteer to participate in a pilot program involving the submission of chemistry, manufacturing, and controls (CMC) information consistent with the new pharmaceutical quality assessment system. The purpose of the pilot program is twofold. First, the pilot program will provide participating pharmaceutical companies with an opportunity to submit critical CMC information that demonstrates their understanding of quality by design, product knowledge, and process understanding of the drug substance and drug product in a new drug application (NDA). Second, the pilot program will enable the public and regulated industry to provide feedback that will assist FDA in developing a guidance for industry on the new quality assessment system.