The U.S. Food and Drug Administration (FDA) recently released a new guidance document that provides recommendations for manufacturers of transdermal drug delivery systems, transmucosal drug delivery systems, and topical patch products on minimizing the amount of drug substance that remains in the product at the end of the labeled use period. In the guidance, entitled Residual Drug in Transdermal and Related Drug Delivery Systems, the FDA explains that, although some amount of surplus drug is typically necessary to maintain appropriate systemic drug levels in the patient, manufacturers should reduce the surplus to the minimum amount possible due to safety risks associated with residual drugs. The guidance is relatively short, but provides some high-level recommendations that focus on the scientific approaches that manufacturers can use to minimize residual drug levels. The FDA’s recommendations apply to investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental new drug applications (sNDAs) for transdermal products.
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