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‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

(Shutterstock)

The reductions in force at the US Food and Drug Administration are beginning to impact Small Business Determinations (SBD), according to Hyman, Phelps & McNamara Director Jennifer Newberger.

On 4 June, the Center for Devices and Radiological Health “sent out an email stating that it would be updating...

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