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Panel: no fixed required number of batches after CMO change; use controlled correspondence
Summary
When a CMO terminates commercial manufacture but supports submission, the agency said there is no fixed required number of batches and recommended sponsors communicate with FDA (control correspondence or meeting) to confirm evidence needs; one batch might be sufficient but not guaranteed.
A participant asked whether an application may proceed when a contract manufacturing organization (CMO) terminates commercial manufacturing but allows use of stability and bioequivalence data for submission, and whether a single additional batch at a new CMO is sufficient for filing.
Dr. Ri replied there is no fixed required number of batches and recommended sponsors work with the agency. "Producing one batch is understandable... but it may not [be enough]," Ri said, recommending controlled correspondence or a meeting request to obtain agency confirmation on evidence expectations for the amendment.
Why it matters: Sponsors facing sudden CMO changes need to know whether their existing data suffice or whether additional batches or studies are required; the agency’s guidance to engage via controlled correspondence is the practical next step.
