USA – US FDA finalizes guidance for post-approval changes

The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.

The US Food and Drug Administration (FDA) has released its final guidance for industry with new International Council for Harmonisation (ICH) guidelines, providing a more predictable and efficient framework for the management of post-approval chemistry, manufacturing and controls changes.

According to the FDA, the recommendations discuss how to identify the elements in an application that are considered necessary to assure product quality and therefore would require a regulatory submission if changed post-approval…