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Pharmaceuticals / Regulatory Affairs

FDA Outlines New Fee Structure Under GDUFA II

Nov. 12, 2019

The FDA laid out user fee program changes under the Generic Drug User Fee Act of 2017 (GDUFA II) in a draft guidance.

Under GDUFA II, which covers fiscal years 2018 through 2022, prior approval fees are no longer required and facilities that manufacture active pharmaceutical ingredients and finished dosage forms (FDFs) only incur FDF fees.

The agency can collect backlog fees from holders of ANDAs that were pending on Oct. 1, 2012 and did not receive a tentative approval prior to that date. The fee was due no later than Nov. 26, 2012. The agency has set the backlog fee at $17,434.

Facilities that qualify as contract manufacturing organizations (CMOs) will pay one-third the amount of the facility fee incurred by FDF facilities that do not qualify as CMOs, the agency said.

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