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Will US FDA User Fee Deal Allow BsUFA Reg Science Research To Start?

 
• By Derrick Gingery

The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.

Grant funding
A regulatory science research program was included in the BsUFA III agreement between the FDA and industry. • Source: Shutterstock

Researchers were ready to launch the inaugural biosimilar regulatory science program, but were forced to wait because the US Food and Drug Administration could not guarantee support for their grants beyond 30 September.

However, now that a deal is in place to include the user fee program reauthorization in the upcoming government funding extension, work may be able to move forward.

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