ATU Sligo /ATU St Angela's

go

Amazon cover image
Image from Amazon.com

FDA regulatory affairs /

Contributor(s): Mantus, David | Pisano, Douglas J.
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
Contents:
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.
Star ratings
    Average rating: 0.0 (0 votes)
Holdings
Item type Current library Call number Copy number Status Date due Barcode Item holds
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 MAN (Browse shelf(Opens below)) 1 Available 0092581
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 MAN (Browse shelf(Opens below)) 1 Available 0092160
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 MAN (Browse shelf(Opens below)) 2 Lost Checked out 22/02/2023 0092575
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 MAN (Browse shelf(Opens below)) 3 Available 0092609
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 MAN (Browse shelf(Opens below)) 4 Available 0092675
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 MAN (Browse shelf(Opens below)) 5 Available 0092587
Total holds: 0

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.

Share