FDA issues final guidance on formal meeting types and timelines for drug and biologics sponsors

The U.S. Food and Drug Administration released final guidance on August 13 that details the types of formal meetings sponsors can request during the development of new drugs and biologics.

The document outlines specific meeting categories and the timelines for submitting requests, aiming to give sponsors clearer expectations throughout the development process.

By standardizing the meeting framework, the FDA seeks to improve communication and planning between the agency and drug and biologics developers.