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Panel: sponsors may propose alternate manufacturing sites; GDUFA amendment review can take ~8–10 months
Summary
Asked whether sponsors can submit an alternate manufacturing site after cGMP/OAI findings, the panel said yes if the alternate is cGMP‑compliant and can produce exhibit batches; review timelines follow GDUFA and may be about 10 months if an inspection is required, otherwise about 8 months.
An online attendee asked whether sponsors can submit information for an alternate drug product manufacturing site after an ANDA receives a complete response letter because the originally proposed site has cGMP problems and an OAI status. Dr. Ri answered that sponsors may propose an alternate site provided it is in good standing with cGMP requirements and can demonstrate the ability to manufacture exhibit batches for evaluation.
Dr. Ri said review timing follows GDUFA performance goals. "If an inspection is needed, it may be longer—10 months if an inspection is needed. Otherwise, 8 months," Ri said, noting that the need for a pre‑approval inspection (PAI) can lengthen review. The panel recommended sponsors communicate with the agency, for example through controlled correspondence or a meeting request, to clarify expectations for batch numbers and evidence requirements.
Why it matters: Sponsors facing manufacturing‑site issues can keep their application moving by proposing a compliant alternate site, but should plan for potential inspection‑driven delays and engage the agency early to confirm documentation and testing expectations.
