Advanced Manufacturing Technology Designation Guidance Uses Broad Criteria For ‘Novel’

 
• By Ramsey Baghdadi

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.

drug manufacturing
FDA guidance describes the new Advanced Manufacturing Technology Designation program. • Source: Shutterstock

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