The US Food and Drug Administration’s draft guidance on the Advanced Manufacturing Technology Designation Program envisions a central role for existing drug and biologic center technology teams in assessing whether a novel manufacturing method qualifies for the new designation.
Advanced Manufacturing Technology Designation Guidance Uses Broad Criteria For ‘Novel’
In US FDA’s draft, mandated by in the current user fee legislation, contract manufacturers can also vie for a designation. CDER ETT and CBER CATT teams will play a key role in the process.
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