Fundamentals of US regulatory affairs
By: RAPS, Regulatory Affairs Professionals Society
Contributors: Regulatory Affairs Professionals Society
Edition: 8th edition.
Publisher: Regulatory Affairs Professionals Society
Published: 2013
Place of publication: Rockville, MD
Language: eng
Number of pages: 540
ISBN-13: 9780982932063
Subjects: Drugs; Law and legislation; Biologicals; Medical instruments and apparatus industry; Pharmaceutical Preparations; Standards; Biological Products; Equipment and Supplies; Government Regulation
Other titles: Fundamentals of United States regulatory affairs
Notes: "Pamela A. Jones, Senior Editor"--Foreword

Includes bibliographical references and index.
Table of contents: title: FDA and related regulatory agencies; title: History of food, drug, and cosmetic laws; title: Overview of drug, biologic, and device and regulatory pathways; title: FDA communications and meetings; title: Preparing for key FDA meetings and advisory committee meetings; title: Crisis management; title: Health technology assessment; title: Good laboratory practice regulations; title: Clinical trials : GCPs, regulations, and compliance; title: Current good manufacturing practice and quality system design; title: Prescription drug submissions; title: Postapproval prescription drug submissions and compliance; title: Generic drug submissions; title: Patents and exclusivity; title: Over-the-counter drug products; title: Prescription drug labeling, advertising, and promotion; title: Pharmacovigilance and risk management; title: Medical device submissions; title: Medical device compliance and postmarketing activities; title: Advertising, promotion, and labeling for medical devices and in vitro diagnostics; title: In vitro diagnostics submissions and compliance; title: Biologics submissions; title: Biologics compliance; title: Biologics labeling, advertising, and promotion; title: Combination products; title: Products for small patient populations; title: Blood and blood products; title: Human cell and tissue products; title: Regulations pertaining to pediatrics; title: Dietary supplements and homeopathic products; title: Cosmetics; title: Veterinary products; title: Food products; title: Companion diagnostics; title: Medical food; title: FDA inspection and enforcement; title: Healthcare fraud and abuse compliance; title: Regulatory information resources in review; title: Comparative matrix of regulations across product lines; title: Glossary.