FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

AAM Calls for Time Estimates, Clarifications in Supply Chain Waiver Guidance

July 12, 2018
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The Association for Accessible Medicines urged the FDA to clarify its draft guidance on Drug Supply Chain Security Act (DSCSA) waivers by adding an estimated timetable for review decisions.

In a public comment, AAM said the FDA should provide an estimate of the typical length of time the agency will take to make a decision on a waiver or exemption request, as an estimate would give manufacturers a better sense of how much time they should budget for meeting compliance deadlines when making a request.

AAM also noted the guidance does not address the notification of potential trade partners. Once a waiver, exemption or exception request is granted by the FDA “all potential trade partners would need to be notified and provided with proof of the authenticity of the claim,” the generic and biosimilar group wrote. The process in the draft guidance appears to include anyone who would own the package at any time, rather than authorized trading partners, AAM said.

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