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

FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics, edited by Douglas J. Pisano, David 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 Mantus
Contributor
Subject
Genre
Language
eng
Summary
This book covers the regulatory process for getting pharmaceuticals, biologics, and medical devices approved. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. Topics include: the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System Compliance and the corresponding documentation requirements, and FDA inspection processes and enforcement options. Although many references exist on this subject, this one is written in a general pros
Cataloging source
N$T
Dewey number
615/.19/00973
Illustrations
illustrations
Index
index present
LC call number
RM301.25
LC item number
.F37 2004eb
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 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
Book Cover; Title; Contents; Overview of Drug Development and the FDA; Regulatory Strategy; What Is an IND?; Formatting, Assembling, and Submitting the New Drug Application (NDA); Meeting with the FDA; Biologics; FDA Medical Device Regulation; The Development of Orphan Drugs; Good Clinical Practices; Good Manufacturing Practices (GMPs) and Enforcement Actions; Electronic Submissions: A Guide for Electronic Regulatory Submissions to the FDA; The Practice of Regulatory Affairs; A Primer of Drug/Device Law or What's the Law and How Do I Find It?; Index
Control code
ocm57049173
Dimensions
unknown
Extent
1 online resource (360 pages)
File format
unknown
Form of item
online
Isbn
9781587160073
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
http://library.link/vocab/ext/overdrive/overdriveId
9780203483657
Quality assurance targets
unknown
http://library.link/vocab/recordID
.b24469373
Sound
unknown sound
Specific material designation
remote
System control number
  • (OCoLC)57049173
  • pebco0203483650

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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