FDA Pharmaceutical Approval Process: An Overview

FDA Pharmaceutical Approval Process

Mounting pressure from the pharmaceutical industry (Industry) has greatly influenced the drug approval process conducted by the U.S. Food and Drug Administration ("FDA").  This pressure has led to the question of who the FDA is actually serving, the health and safety of the public or the Industry? According to Sidney Wolfe, M.D., Director of Public Citizen’s Health Research Group, the Industry is exerting its influence on the FDA in three distinct ways: The Prescription Drug User Fee Act, passed in 1992, provides... Read More