U.S. Food and Drug Administration: Review for the Emergency Physician of Approval Process and Limitations.

Bhavesh Patel,Nadia Zuabi,Mark Langdorf

doi:10.5811/westjem.2016.8.31197

Abstract

U.S. Food and Drug Administration: Review for the Emergency Physician of Approval Process and Limitations.

Highlights

Emergency physicians (EP) frequently are exposed to promotion for drugs and devices through professional organizations and meetings, journals, and direct-to-consumer pharmaceutical advertising (DTCPA)
The Food and Drug Administration (FDA) relies on congressional oversight to safeguard 25% of products and services consumed in the U.S.,6 robust lobbying influences regulation of these products, which enhances pharmaceutical industry profits.[7]
12 Title 21 of the Code of Federal Regulations (CFR) is reserved for the FDA and outlines rules published in the Federal Register by executive departments and federal government agencies related to DTCPA.[13]

Summary

UC Irvine

Western Journal of Emergency Medicine: Integrating Emergency Care with Population Health Title U.S Food and Drug Administration: Review for the Emergency Physician of Approval Process and Limitations Journal Western Journal of Emergency Medicine: Integrating Emergency Care with Population Health, 17(6)

Review Article

INTRODUCTION

Review of the FDA Approval Processes and Limitations

Findings

CONCLUSION