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    Drug Companies Reveal Shortcomings in FDA Draft Guidance on Generic Topical Patches

    Mylan, Perrigo, AstraZeneca and Apotex are seeking more clarity and raising questions with the shortcomings of US Food and Drug Administration (FDA) draft guidance aiming to improve the way adhesion data is used for abbreviated new drug application (ANDA) submissions of transdermal delivery systems and topical patches. The draft guidance, released in May , describes the recommended approach for an adhesion clinical study design and, once finalized, the guidance will sup...