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Panel: FDA does not mandate specific drying‑endpoint methods but expects scientific justification and full data
Summary
Asked about establishing reproducible primary/secondary drying endpoints, the panel said FDA does not mandate specific methods; sponsors must provide scientifically justified development and validation data and may choose among multiple accepted approaches.
A questioner asked what the FDA recommends for establishing scientifically sound and reproducible methods for determining primary and secondary drying endpoints, noting that incorrectly identifying drying endpoints is a common deficiency.
Dr. Ri answered that the agency does not mandate specific methods, and that sponsors should pick fit‑for‑purpose tools and provide a complete set of process development and validation data demonstrating the adequacy of the chosen approach. "We as an agency don't mandate specific methods... give us a full set of data," Ri said. The panel also noted literature and available PAT tools that can be selected based on product and process needs; a panelist referenced a paper by Commander Reed and colleagues on regulatory considerations for live products.
Why it matters: Drying‑endpoint determination affects product quality and stability for lyophilized or dried products; sponsors must substantiate their method choice with data in regulatory submissions rather than relying on institutional experience alone.
