The Experiment in Post-Marketing Surveillance of Prescription Drugs: An Initial Status Report

摘要

This study examines baseline information on the continuing administrative experiment in changes in the regulatory process for prescription drugs. The experiment deals with changes in post marketing surveillance and their impact on the drug approval process and on innovation in the drug industry and health care in general. The baseline information includes data and analysis covering effects on innovation, the Food and Drug Administration regulatory decisions and the pharmaceutical industry. The study also includes recommendations for continuing the experiment and measuring its effects.