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

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

Label
FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics
Title
FDA regulatory affairs
Title remainder
a guide for prescription drugs, medical devices, and biologics
Statement of responsibility
edited by Douglas J. Pisano, David S. Mantus
Contributor
Subject
Genre
Language
eng
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
Cataloging source
N$T
Dewey number
615/.19
Illustrations
illustrations
Index
index present
LC call number
RM301.25
LC item number
.F37 2008eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Label
FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics, edited by Douglas J. Pisano, David S. Mantus
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
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
Control code
ocn284975585
Dimensions
unknown
Edition
2nd ed
Extent
1 online resource (viii, 448 pages)
File format
unknown
Form of item
online
Isbn
9781420073553
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
Quality assurance targets
not applicable
http://library.link/vocab/recordID
.b24474915
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • (OCoLC)284975585
  • pebco1420073559

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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