E-Submission Part Of FDA Reg Reform Plan; Alzheimer’s Data Standard About To Debut
Standards for organizing clinical data from research in some major diseases are taking shape as FDA moves to clear a regulatory path that eventually could allow all submissions to be done electronically.
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Technical deficiencies foil the resubmission of Chelsea Therapeutics’ Northera. The company thinks it can resolve the problems quickly and some analysts expect a relatively short delay of one or two months to the user fee date.
Safeguarding America’s Pharmaceuticals Act passes on suspension calendar, but likely sets up fight with Senate in conference.