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Safety Reporting: It Can Enter the 21st Century-If We Let It
Jonathan Seltzer1, Amit Bhattacharyya1
11 ACI Clinical, Bala Cynwyd, PA, USA.
Therapeutic Innovation & Regulatory Science
|May 2, 2018
Abstract:
This is a commentary about the evolution of safety reporting, the new FDA Draft Guidance on Safety Reporting and possible paths forward.
Keywords:
IND Safety Reporting.clinical trial safetydata monitoring committeesafety assessment committeesafety reportingMore Related Videos
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