FDA PreCheck Pilot Selects Seven Companies to Expand U.S. Drug Manufacturing Capacity
- FDA announced selection of seven companies for PreCheck Pilot Program, a new initiative providing early regulatory guidance and predictable pathways for domestic pharmaceutical manufacturing facilities.
- Selected participants include Amneal Pharmaceutical (sterile liquids, Long Island), Cellares (cell-based gene therapy, New Jersey), Eli Lilly (APIs, Indiana), FUJIFILM Biotechnologies (cell culture, North Carolina), Kriya Therapeutics (AAV gene therapy, North Carolina), Kyowa Kirin (drug substance, North Carolina), and Regeneron (biologics/injectables, New York).
- Two-phase model provides facility-readiness technical guidance via Drug Master Files and expedited pre-submission meetings to accelerate FDA inspection and application review cycles.
Operational Impact
FUJIFILM Biotechnologies' Holly Springs cell-culture facility gains predictable FDA regulatory milestones and early technical guidance, potentially accelerating commercial-scale biomanufacturing timelines and reducing inspection uncertainty for clients seeking domestic biologics capacity.
Source: FDA Press Releases RSS