An edition of Fundamentals of US regulatory affairs
(2011)
Fundamentals of US regulatory affairs
7th ed.
by Regulatory Affairs Professionals Society
- 1 Want to read
- 0 Currently reading
- 0 Have read
Share
×Close
This edition doesn't have a description yet. Can you add one?
Check nearby libraries
Buy this book
Showing 1 featured edition. View all 1 editions?
| Edition | Availability |
|---|---|
1
Fundamentals of US regulatory affairs
2011, RAPS, Regulatory Affairs Professionals Society
in English
- 7th ed.
098293212X 9780982932124
|
aaaa
Libraries near you:
WorldCat
|
Book Details
Table of Contents
History of FDA and related regulatory agencies / by Richard Morroney and Nandini Murthy
History of food, drug, and cosmetic laws / by Nandini Murthy and Richard Morroney
Overview of drug, biologic, and device regulatory pathways / by Scott A. Oglesby
FDA communications and meetings / by Cindy DiBiasi and Kell Cannon
Preparing for key FDA meetings and advisory committee meetings / by Cindy DiBiasi
Good laboratory practice regulations / updated by Kurt Stahl and Dana Dunn
Clinical trials : GCPs, regulations, and compliance / updated by Grant S. Griffin
Current good manufacturing practice and quality system design / by Christopher Ernst
Prescription drug submissions / by Naseem Kabir
Postapproval prescription drug submissions and compliance / by William C. Putnam and Miguel A. de Soto-Perera
Generic drug submissions / by Kurt R. Karst
Patents and exclusivity / by Kurt R. Karst
Over-the-counter drug products / updated by Alice J. Welenc-Masters and David J. Schifkovitz
Prescription drug labeling, advertising, and promotion / by John Driscoll and Linda Pollitz
Medical device submissions / by Chas Burr and John DeLucia
Medical device compliance and postmarketing activities / by Richard Angelo
Advertising, promotion, and labeling for medical devices and IVDs / updated by Kelly Rowland
In vitro diagnostics submissions and compliance / by Michael Wienholt
Biologics submissions / by Marcia Gaido
Biologics compliance / by Marcia Gaido
Biologics labeling, advertising, and promotion / updated by Moulakshi Roychowdhury
Combination products / by Mark D. Kramer
Regulation of products for small patient populations / updated by Hari Nagaradona
Blood and blood products / by Sue Sutton-Jones
Human cell and tissue products / by Martha Wells
Regulations pertaining to pediatrics / by Susan Hamann
Dietary supplements and homeopathic products / by Maruthi Prasad Palthur and Evelyn Cadman
Cosmetics / by Evelyn Cadman
Veterinary products / updated by Jeff Zinza
Food products / updated by Evelyn Cadman
FDA inspection and enforcement / by Alan Minsk and William H. Kitchens
Healthcare fraud and abuse compliance / updated by Jennifer D. Burgar
Regulatory information resources in review / by Diane R. Whitworth
Comparative matrix of regulations across product lines
Glossary of terms.
Edition Notes
Includes bibliographical references and index.
Classifications
The Physical Object
ID Numbers
Community Reviews (0)
Feedback?
| October 28, 2020 | Created by MARC Bot | import new book |