Table of Contents
Table of Contents
Preface
Chapter 1. Drug Safety: FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement
United States Government Accountability Office
Chapter 2. Statement of Janet Woodcock, Director, Center for Drug Evaluation and Research, Food and Drug Administration. Hearing on ”21st Century Cures: Incorporating the Patient Perspective”
Chapter 3. Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics
Food and Drug Administration
Index