FDA's Biosimilars Meeting Management Should Improve After Reorg In New Drug Office

US FDA met more biosimilar user fee program meeting performance goals in FY 2018 compared to prior year but still fell short in scheduling for three of five types of meetings. Office of New Drugs reorganization, once completed, should address some logistical scheduling issues.

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The FDA met most of its performance goals under the first year of the BsUFA II agreement. • Source: Shutterstock

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