Kate Rawson
When the board of the Pharmaceutical Research & Manufacturers of America was briefed on the first prescription drug user fee...
The New User Fee Rules: FDA Sacrifices Timeliness, Tries to Save Predictability
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Janet Woodcock is returning as director of CDER at a time when the user fee program is in flux and FDA is struggling to implement new drug safety initiatives. For 2008, timeliness of reviews will slip, but with any luck, the transparency and predictability of PDUFA will continue.
Learn what's happening at the US FDA. On the go.
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