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Presenter: rapotretinib example shows when fed studies can be waived with sufficient evidence
Summary
Using rapotretinib as an example, the presenter said the agency initially classified it as high‑risk with multiple study recommendations but described an alternate pathway that can waive fed studies when fasting results, dissolution, and qualitative/quantitative formulation comparisons justify it.
The presenter discussed rapotretinib tablets as an example of where alternate approaches may be acceptable. She said the initial FDA classification for rapotretinib was high‑risk, with recommendations for multiple studies across strengths and conditions, but that a fed study might be waived if fasting results, dissolution similarity, and qualitative/quantitative formulation comparisons between test and RLD demonstrate minimal risk of different in vivo behavior in fed conditions.
She emphasized that such alternative pathways require careful comparison of critical excipients and formulation Q/QA (qualitative/quantitative assessment). Where the RLD contains solubilizing agents or pH modifiers, the agency wants to see strong evidence that the test product is comparable before accepting a waiver.
