FDA regulatory affairs /
Contributor(s): Mantus, David | Pisano, Douglas J
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Publisher: Boca Raton, FL : CRC Press, Taylor & Francis Group, 2014Edition: Third edition.Description: xii, 387 p. : ill. ; 24 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 9781841849195(hardcover : acidfree paper); 9781841849195; 1841849197(hardcover : acid-free paper).Subject(s): Drug development -- United States | United States. Food and Drug Administration -- Rules and practiceDDC classification: 615.19 Item type | Current library | Call number | Copy number | Status | Date due | Barcode | Item holds |
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ATU Sligo Yeats Library Main Lending Collection | 615.19 MAN (Browse shelf(Opens below)) | 1 | Available | 0092581 | ||
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ATU Sligo Yeats Library Main Lending Collection | 615.19 MAN (Browse shelf(Opens below)) | 1 | Available | 0092160 | ||
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ATU Sligo Yeats Library Main Lending Collection | 615.19 MAN (Browse shelf(Opens below)) | 2 | Lost Checked out | 22/02/2023 | 0092575 | |
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ATU Sligo Yeats Library Main Lending Collection | 615.19 MAN (Browse shelf(Opens below)) | 3 | Available | 0092609 | ||
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ATU Sligo Yeats Library Main Lending Collection | 615.19 MAN (Browse shelf(Opens below)) | 4 | Available | 0092675 | ||
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ATU Sligo Yeats Library Main Lending Collection | 615.19 MAN (Browse shelf(Opens below)) | 5 | Available | 0092587 |
Includes bibliographical references and index.
Preface / David S. Mantus and Douglas J. Pisano-- Editors -- Contributors -- Chapter 1 :overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- Chapter 2 : what is an IND? / Michael R. Hamrell -- Chapter 3 : the new drug application / Charles Monahan and Josephine C. Babiarz -- Chapter 4 : meetings with the FDA / Alberto Grignolo and Sally Choe -- Chapter 5 : FDA medical device regulation / Barry Sall -- Chapter 6 : a primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- Chapter 7 : the development of orphan drugs / Scott N. Freeman -- Chapter 8 : CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke and Kevin Swiss -- Chapter 9 : overview of the GxPs for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- Charpet 10 : FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake, Esq. -- Chapter 11 : the practice of regulatory affairs / David S. Mantus -- Chapter 12 : FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Chapter 13 : biologics / Florence Kaltovich -- Cahpter 14 : regulation of combination products in the United States / John Barlow Weiner, Esq -- Index.