1. Pink Sheet

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

 
• By Sue Sutter

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

The US Food and Drug Administration believes that completion of the still-ongoing reorganization of its Office of New Drugs, coupled with hiring initiatives, will improve its ability to satisfy biosimilar user fee meeting management goals in the coming years.

The FDA’s biosimilar user fee (BsUFA II) program missed fewer meeting performance goals in fiscal year 2018 compared to the prior year but

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