Resources for Food and Drug Administration (FDA)

FDA evolves application process

www.in-pharmatechnologist.com

The US Food and Drug Administration (FDA) is continuing to evolve in the face of current challenges through the launch of two new initiatives. Firstly the agency has called time on its "approvable" and "not approvable" responses to drug applications, replacing it with a "complete response". This brings the approval response into line with biologic license applications. The "complete response" will detail specific flaws in the application and recommendations as to how to achieve approval.

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