1. Pink Sheet

US FDA Publishes, Then Withdraws, PDUFA Rates Because Process ‘May Not Be Well Understood’

 
• By Derrick Gingery

User fees for FY 2021 were set to increase nearly 11%, but could have gone even higher; a new notice will be issued but timing is unclear.

Cash drawer with currency
FDA officials announced the new prescription drug user fees, but then withdrew the notice. • Source: Alamy

US Food and Drug Administration officials decided to pull the announcement of fiscal year 2022 prescription drug user fees apparently due to a misunderstanding of the calculations.

The unusual move came as the agency had decided to raise application fees nearly 11% and the program fee more than 12%. Sponsors were going to be charged nearly $3.2m for applications requiring clinical data and nearly $1

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US FDA Advisory Committee Misperceptions Abound … At HHS

 
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