1. Pink Sheet

Off The Clock? The New Timelines Of “Real-Time Review”

 
• By Michael McCaughan

When is a two-week review not a two-week review? When it is part of the US FDA’s Oncology Center of Excellence “real-time review” pilot program. The “left shifted” review pilot is off to a good start, but it may be time to rethink the concept of FDA review clocks.

Clock numbers in close up
The US FDA and sponsors may need to rethink how they look at the review clock. • Source: Susana Fernandez

Novartis AG, Amgen Inc., and Seattle Genetics Inc. have all had a common experience in 2018: each sponsor has received US FDA approval for a supplemental application less than a month after completing the submission – before they would normally even have been notified that the filing was accepted.

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