CDER Proposes Supersizing Office of Generic Drugs

CDER is looking to elevate the Office of Generic Drugs (OGD) into a “super” office, a move necessitated by the recent passage of the Generic Drug User Fee Amendments (GDUFA) and a heightened public focus on generic medicines, Center Director Janet Woodcock said.

Under this plan, the OGD and its newly appointed director, Greg Geba, would report directly to Woodcock. Acting Director of the Office of Executive Programs Mary Beth Clarke would continue to be the CDER lead on GDUFA implementation, Woodcock added in a letter to CDER staff. Clarke would work closely with OGD and other CDER groups to implement the new user fee program.

OGD’s elevation would put the office on par with other super offices such as the Office of New Drugs and the Office of Compliance, which became a super office last summer. The new status would also allow OGD to house subordinate offices.

GPhA supports the supersized generics office, President and CEO Ralph Neas said.

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