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Lawyer Applauds Combo Products Guide But Says Some Details Missing

By David Roza
August 1, 2019 at 11:35 AM
A recently issued final FDA guidance clarifies key industry questions about how combination product makers should comply with postmarket safety reporting requirements (PMSR), but an industry lawyer said some of the finer points, such as details to be included in foreign event reports and the number of constituent parts in a safety report, will have to be hashed out in practice. The guidance, released July 22, aims to flesh out the requirements laid out in a 2016 final rule, which...


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