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FDA’s Post Marketing Requirements of Approved Drugs Is A Major Step to Enhance Drug Safety and Public Health

Wednesday, September 12, 2018 — Poster Session I

12:00 p.m. – 1:30 p.m.
FAES Terrace
OD
RSCHSUPP-17

Authors

  • P Panneerselvam
  • f Provorny
  • S Ferguson

Abstract

Drugs are vigilantly reviewed by Food and Drug Administration (FDA) during clinical trial. However clinical trial involves only several hundred to several thousand patients. In recent years, drugs those are first in class, those serving new market or those serve pressing demands undergo smaller clinical trial with surrogate end points. Hence, all possible side effects of a drug cannot be anticipated during drug approval process. Post Market Surveillance is phase 4 clinical trial, that is designed to capture these adverse side effects that did not appear during drug approval process. The project is focused at assessing postmarket safety events associated with novel cancer therapeutics (Biologics). This project is aimed at understanding the adverse events associated with accelerated drug approval and efforts taken by FDA to maintain the safety of public health. This study will help to appreciate the current role of FDA in drug approval process.

Category: Research Support Services