CDER Office of Pharmaceutical Quality Division of Biopharmaceutics’ Om Anand shares how to decrease Refuse to Receive (RTR), Information Request (IR), and Complete Response (CR) regulatory actions due to
dissolution deficiencies, and increase approval during first review cycle from a a biopharmaceutics perspective. He discusses FDA inadequate and adequate dissolution submissions. He covers ANDAs and RTR regulatory actions related to dissolution deficiencies, considerations for selection of dissolution method & criteria/criterion, common dissolution deficiencies, and future directions. A top RTR is due to inadequate dissolution.

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