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PDUFA VII negotiations near finish line with plans to revamp CBER and staff up – Endpoints News

Negotiations for the next Prescription Drug User Fee Act (PDUFA VII) are approaching their end as both FDA and biopharma industry reps agreed in their last steering…

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How does one decide who makes an under 40 list? After the last nominations come in from staff and readers, were left to sort through hundreds of names, with no obvious guideposts for how to do so. Do we want the basic scientist behind a major discovery, or the executive working to translate it into medicines? The venture capitalist spinning out a half-dozen companies or the founder with one big idea? Leaders who have already brought drugs into the clinic or leaders who seem on the cusp of it?
Ultimately,…

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