Facility Readiness Archives - Quality Solutions Now (QSN)

FDA PreCheck and the New Facility Readiness Mindset
On June 29, 2026, FDA announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative intended to advance U.S. drug manufacturing and improve regulatory predictability for new domestic [...]
FDA’s New Guidance on “Alternative Tools” for Manufacturing Facility Assessments: What Life Sciences Companies Need to Know
The FDA issued a new guidance on the use of “alternative tools” for assessing manufacturing facilities as part of the drug and biologics approval process. This guidance, titled "Alternative Tools for Assessing Manufacturing Facilities Named [...]