The Resource FDA regulatory affairs, editors, Douglas J. Pisano, David Mantus

FDA regulatory affairs, editors, Douglas J. Pisano, David Mantus

Label
FDA regulatory affairs
Title
FDA regulatory affairs
Statement of responsibility
editors, Douglas J. Pisano, David Mantus
Contributor
Editor
Subject
Language
eng
Cataloging source
N$T
Dewey number
615/.19
Index
index present
LC call number
RM301.25
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Label
FDA regulatory affairs, editors, 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
Overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- What is an IND? / Michael R. Hamrell -- The new drug application / Charles Monahan and Josephine C. Babiarz -- Meetings with the FDA / Alberto Grignolo and Sally Choe -- FDA medical device regulation / Barry Sall -- A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- The development of orphan drugs / Scott N. Freeman -- CMC sections of regulatory filings and CMC regulatory -- Compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- Overview of the gxps for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- The practice of regulatory affairs / David S. Mantus -- FDA advisory / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner
Control code
ocn869462369
Dimensions
unknown
Extent
1 online resource
File format
unknown
Form of item
online
Isbn
9781841849201
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Quality assurance targets
not applicable
http://library.link/vocab/recordID
.b30403212
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • (OCoLC)869462369
  • CRC1841849200

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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