ECU Libraries Catalog

FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics / edited by Douglas J. Pisano, David S. Mantus.

Other author/creatorPisano, Douglas J.
Other author/creatorMantus, David.
Format Book and Print
Edition2nd ed.
Publication InfoNew York : Informa Healthcare USA, ©2008.
Descriptionviii, 448 pages : illustrations ; 24 cm
Subject(s)
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.
Bibliography noteIncludes bibliographical references and index.
LCCN 2008014296
ISBN9781420073546 :
ISBN1420073540

Available Items

Library Location Call Number Status Item Actions
Laupus Books - Stacks QV 744 F293 2008 ✔ Available Place Hold

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