2022-22334: Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in a New Drug Application, Abbreviated New Drug Application, or Biologics License Application; Guidance for Industry; Availability

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA." This final guidance is intended to assist original applicants and holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) on implementing a chemistry, manufacturing, and controls (CMC) postapproval change(s) through the use of a comparability protocol (CP). In many cases, submission and approval of a CP will facilitate the subsequent implementation and reporting of CMC changes, which could result in moving a drug or biological product into distribution or facilitating a proactive approach to reinforcing the supply of a product sooner than if a CP were not used. This final guidance recommends a framework to promote continuous improvement in the manufacturing of quality drug and biological products. This document finalizes a revised draft guidance that published on April 20, 2016, entitled "Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information." A related draft guidance entitled "Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information" that published in September 2003, was withdrawn on May 6, 2015.

The agency’s own summary, as published.