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US FDA’s Novel Approval Count Hits 32 In First Half Of 2021, With More Than 40 Goal Dates Ahead

 
• By Bridget Silverman

CDER approved a record 27 novel agents between January and June, while a wave of cell therapy and vaccine applications could carry the biologics center to new heights. Merck could close year with four novel approvals.

The strength of the regulatory system set up by the Prescription Drug User Fee Act (PDUFA) and its reauthorizations has been highlighted by the US FDA’s strong and consistent performance on review metrics during the disruptions of a historic disease outbreak.

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