FDA Regulatory Affairs PDF

Preface

This book is a roadmap to the U.S. Food and Drug Administration (FDA) and drug, biologic, and medical device development. The book is written in plain English, with an emphasis on easy access to understanding how this Agency operates with respect to the practical aspects of U.S. product approval. It is meant to be a concise reference that offers current, real-time information. It has been written as a handy reference for use by students, staff, and professionals at corporations, organizations, and schools and colleges across the United States in need of a simple, concise text from which to learn and teach. The topics in FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition, are covered in a straightforward format. It is a compilation and commentary of selected laws and regulations pertaining to the development and approval of drugs, biologics, and medical devices in the United States. It is not intended to take the place of an actual reading of the laws of the United States of America or the regulations of the United States, its agencies or anybody that regulates the development or approval of drugs, biologics, and medical devices in the United States.