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Initiatives to Strengthen FDA’s Generic Drug Review Process Include OGD Supplement and Peptide Teams

Sep 4th, 2012

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FDA’s Office of Generic Drugs (OGD) has created dedicated teams for the review of supplements and peptide drugs as part of an office-wide effort to improve the efficiency and effectiveness of its review processes and explore where policy and resource improvements are needed.

The supplement and peptide teams join other teams that OGD has created focused on Drug Master Files (DMFs) (IPQ “The News in Depth” August 30, 2012) and stability – also intended to streamline workflows and prepare for implementation of the Generic Drug User Fee Amendments (GDUFA).

A key driver for the OGD efforts is the expanded backlog of generics filings and the agreements reached through the user fee negotiations.  Additionally, workflows need to be examined with respect to which activities under GDUFA will require the applicant to pay fees and which will not.

At a CMC workshop co-sponsored by the Generic Pharmaceutical Association (GPhA) and FDA in late May in Bethesda, Maryland, OGD Acting Director and Office of Pharmaceutical Science (OPS) Deputy Director Keith Webber explained why the supplement review team was formed and what it is intended to accomplish.

He pointed out that the office receives changes in the form of CBE-30s, CBE-0s, and prior approval supplements, which the new team will manage “in a more organized fashion.”

Some of the CBEs “can be processed relatively quickly because they are less risky changes than prior approval supplements, which take more review and attention,” Webber noted.  The team will triage incoming change requests with regard to potential risk and time required for review and “manage the process better.”

[More on the OGD initiatives and how they meld with developments CDER-wide is provided for subscribers beginning on page 2.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected].  For subscription/license information, click here.]

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