Fundamentals of US regulatory affairs
By: RAPS, Regulatory Affairs Professionals Society
Edition: 7th ed.
Publisher: RAPS, Regulatory Affairs Professionals Society
Published: 2011
Place of publication: Rockville, MD
Language: eng
Number of pages: 460
ISBN-13: 9780982932124
Subjects: Pharmaceutical Preparations; Biologicals; Drugs; Medical instruments and apparatus industry; Law and legislation; Biological Products; Standards; Equipment and Supplies; Government Regulation
Other titles: Fundamentals of United States regulatory affairs
Notes: Includes bibliographical references and index.
Table of contents: title: History of FDA and related regulatory agencies / by Richard Morroney and Nandini Murthy; title: History of food, drug, and cosmetic laws / by Nandini Murthy and Richard Morroney; title: Overview of drug, biologic, and device regulatory pathways / by Scott A. Oglesby; title: FDA communications and meetings / by Cindy DiBiasi and Kell Cannon; title: Preparing for key FDA meetings and advisory committee meetings / by Cindy DiBiasi; title: Good laboratory practice regulations / updated by Kurt Stahl and Dana Dunn; title: Clinical trials : GCPs, regulations, and compliance / updated by Grant S. Griffin; title: Current good manufacturing practice and quality system design / by Christopher Ernst; title: Prescription drug submissions / by Naseem Kabir; title: Postapproval prescription drug submissions and compliance / by William C. Putnam and Miguel A. de Soto-Perera; title: Generic drug submissions / by Kurt R. Karst; title: Patents and exclusivity / by Kurt R. Karst; title: Over-the-counter drug products / updated by Alice J. Welenc-Masters and David J. Schifkovitz; title: Prescription drug labeling, advertising, and promotion / by John Driscoll and Linda Pollitz; title: Medical device submissions / by Chas Burr and John DeLucia; title: Medical device compliance and postmarketing activities / by Richard Angelo; title: Advertising, promotion, and labeling for medical devices and IVDs / updated by Kelly Rowland; title: In vitro diagnostics submissions and compliance / by Michael Wienholt; title: Biologics submissions / by Marcia Gaido; title: Biologics compliance / by Marcia Gaido; title: Biologics labeling, advertising, and promotion / updated by Moulakshi Roychowdhury; title: Combination products / by Mark D. Kramer; title: Regulation of products for small patient populations / updated by Hari Nagaradona; title: Blood and blood products / by Sue Sutton-Jones; title: Human cell and tissue products / by Martha Wells; title: Regulations pertaining to pediatrics / by Susan Hamann; title: Dietary supplements and homeopathic products / by Maruthi Prasad Palthur and Evelyn Cadman; title: Cosmetics / by Evelyn Cadman; title: Veterinary products / updated by Jeff Zinza; title: Food products / updated by Evelyn Cadman; title: FDA inspection and enforcement / by Alan Minsk and William H. Kitchens; title: Healthcare fraud and abuse compliance / updated by Jennifer D. Burgar; title: Regulatory information resources in review / by Diane R. Whitworth; title: Comparative matrix of regulations across product lines; title: Glossary of terms.