1. Pink Sheet

After ODAC: The State Of Accelerated Approval At The US FDA

 
• By Michael McCaughan

US FDA’s Accelerated Approval process has always been a deceptively simple idea. After a three-day public review of ‘dangling’ applications, the underlying complexity remains.

Will Pazdur be able to tell his fellow oncologists that the state of accelerated approval is strong?

So now what?

That question comes to the fore now that the Oncologic Drugs Advisory Committee has completed its review of the status...

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