Cellares Accepted to FDA's Inaugural Manufacturing PreCheck Cohort, the Only Cell Therapy Platform Among Seven Companies Nationwide

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today announced its acceptance into the U.S ...

Eli Lilly, Regeneron join FDA pilot designed to accelerate US manufacturing readiness

The U.S. Food and Drug Administration (FDA) on Monday named seven companies selected for its FDA PreCheck Pilot Program. The ...
TMCnet

FDA Selects Kyowa Kirin for PreCheck Pilot Program to Accelerate Manufacturing Timelines and Enhance Supply Chain Resilience

Strategic collaboration at Sanford, North Carolina facility, currently under construction, to optimize cGMP validation, accelerate time-to-market for complex biologics, and shore up U.S. medicine ...
The Regulatory Review

Training Records and the Limits of Compliance Evidence

Regulators require organizations to create and retain records because documentation makes compliance visible. Recordkeeping ...