FDA Meeting to Focus on Onshoring Drug and Biological Products Manufacturing

The Food and Drug Administration will host a hybrid meeting on Sept. 30 to request feedback on the agency’s proposal for FDA PreCheck, a program designed to accelerate the development of high-priority pharmaceutical manufacturing facilities and strengthen the U.S. drug supply chain.

FDA PreCheck consists of two phases: a facility readiness phase and an application submission phase.

During the facility readiness phase, selected manufacturers will engage with FDA for early technical advice before a facility is operational. This will consist of pre-operational reviews and utilization of a facility-specific drug master file to facilitate efficient evaluation of facility-specific elements prior to, and in support of, drug application submissions.

During the application submission phase, FDA will engage with manufacturers through pre-submission meetings to resolve issues and expedite assessments of quality information in a drug application and inspections. 

In the meeting, FDA will seek feedback on what stakeholders consider the most significant regulatory hurdle in establishing a new domestic pharmaceutical manufacturing facility, which elements of the FDA PreCheck proposal are most likely to help establish new manufacturing facilities, and additional elements or implementation considerations that could be incorporated in the proposal. The agency also invites manufacturers to provide information about manufacturing facilities relevant to FDA oversight.

In-person and virtual registration information is available online.