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Title FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics / edited by Douglas J. Pisano, David S. Mantus.
Imprint New York : Informa Healthcare USA, ©2008.


 Internet  Electronic Book    AVAILABLE
Edition 2nd ed.
Description 1 online resource (viii, 448 pages) : illustrations
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Print version record.
Subject United States. Food and Drug Administration -- Rules and practice.
United States. Food and Drug Administration.
United States. Food and Drug Administration.
Drug development -- United States.
Pharmaceutical industry -- United States.
United States.
United States Government Agencies.
Biological Factors -- standards.
Equipment and Supplies -- standards.
Government Regulation.
Drug Approval.
Drug Approval -- United States.
United States Government Agencies -- United States.
Biological Products -- standards -- United States.
Equipment and Supplies -- standards -- United States.
Government Regulation -- United States.
United States.
Genre Electronic book.
Contents Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahé Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer.
Summary Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.
Other Author Pisano, Douglas J.
Mantus, David.
Other Title Print version: FDA regulatory affairs. 2nd ed. New York : Informa Healthcare USA, ©2008 9781420073546 1420073540