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US FDA's Generics Program Reaches 'Steady State' Milestone

Executive Summary

OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.

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Susan Rosencrance, who helped negotiate GDUFA III, will take over as acting director of the Office of Generic Drugs following Sally Choe’s departure on 8 October. Former OGD head Uhl says the director needs to be the ‘number one advocate for the generic drug program inside the agency.’

GDUFA Research Impacting Generic Development, ANDA Approvals

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

GDUFA Research Impacting Generic Development, ANDA Approvals

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

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