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Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.
Robbins 1 January 2023 Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification.
Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.
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