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

Contributor(s): Material type: TextTextPublication details: New York : Informa Healthcare USA, c2008.Edition: 2nd edDescription: viii, 448 p. : ill. ; 24 cmISBN:
  • 9781420073546 (hbk. : alk. paper)
  • 9781420073546 (Cloth)
Subject(s): DDC classification:
  • 615.19 PIS
LOC classification:
  • RM301.25 .F37 2008
Online resources:
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.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
Short Loan TUS: Midlands, Main Library Athlone General Lending 615.19 PIS (Browse shelf(Opens below)) 1 Available 00214449
Short Loan TUS: Midlands, Main Library Athlone General Lending 615.19 PIS (Browse shelf(Opens below)) 1 Available 00214448

Includes bibliographical references and index.

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.

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