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

FDA regulatory affairs, edited by David Mantus, Douglas J. Pisano

Label
FDA regulatory affairs
Title
FDA regulatory affairs
Statement of responsibility
edited by David Mantus, Douglas J. Pisano
Contributor
Editor of compilation
Subject
Genre
Language
eng
Cataloging source
DNLM/DLC
Index
index present
LC call number
RM301.25
LC item number
.F37 2014
Literary form
non fiction
Nature of contents
bibliography
NLM call number
QV 771 F287 2014
http://library.link/vocab/relatedWorkOrContributorName
  • Mantus, David
  • Pisano, Douglas J.
http://library.link/vocab/subjectName
  • United States
  • United States
  • United States
  • Drug development
  • Pharmaceutical industry
  • Drug Approval
  • United States Government Agencies
  • Biological Products
  • Equipment and Supplies
  • Government Regulation
  • Drug development
  • Pharmaceutical industry
  • United States
Label
FDA regulatory affairs, edited by David Mantus, Douglas J. Pisano
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
Carrier category
volume
Carrier MARC source
rdacarrier
Content category
text
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, Esq. -- The practice of regulatory affairs / David S. Mantus -- FDA advisory Committees / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner, Esq
Dimensions
24 cm
Edition
Third edition.
Extent
xii, 387 pages
Isbn
9781841849195
Isbn Type
(hardcover : acid-free paper)
Lccn
^^2013047346
Media category
unmediated
Media MARC source
rdamedia
System control number
  • (OCoLC)864382873
  • (OCoLC)ocn864382873
Label
FDA regulatory affairs, edited by David Mantus, Douglas J. Pisano
Publication
Bibliography note
Includes bibliographical references and index
Carrier category
volume
Carrier MARC source
rdacarrier
Content category
text
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, Esq. -- The practice of regulatory affairs / David S. Mantus -- FDA advisory Committees / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner, Esq
Dimensions
24 cm
Edition
Third edition.
Extent
xii, 387 pages
Isbn
9781841849195
Isbn Type
(hardcover : acid-free paper)
Lccn
^^2013047346
Media category
unmediated
Media MARC source
rdamedia
System control number
  • (OCoLC)864382873
  • (OCoLC)ocn864382873

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