FDARA Takes Effect With Under-The-Radar Presidential Signature
Key FDA legislation moves to implementation phase with presidential signature but little fanfare.
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The CDER director said the US agency is always thinking about the next iteration of the prescription drug user fee program, but added that it has not yet discussed specifics.
US House passage sends legislation back to Senate, where it may not garner widespread support.
In a journal article, Center for Drug Evaluation and Research Director Janet Woodcock and colleagues describe the sources of real-word evidence and study designs that can be used to generate such evidence.