1. Pink Sheet

US FDA’s Accelerated Approval Reforms Include Dispute Resolution For Withdrawals

 
• By Derrick Gingery

Allowing decisions to be reviewed by higher management levels, rather than convening administrative hearings, could save time in the withdrawal process.

Dispute resolution
The FDA wants its dispute resolution process to apply to accelerated approval withdrawals. • Source: Alamy

Dispute resolution is the US Food and Drug Administration’s preferred process for withdrawing accelerated approvals, a route that could dramatically speed up the slow and time-consuming exercise.

In its

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