FDA regulatory affairs /
FDA regulatory affairs /
- Third edition.
- Boca Raton, FL : CRC Press, Taylor & Francis Group, 2014.
- xii, 387 p. : ill. ; 24 cm.
Includes bibliographical references and index.
Preface / Editors -- Contributors -- Chapter 1 :overview of FDA and drug development / Chapter 2 : what is an IND? / Chapter 3 : the new drug application / Chapter 4 : meetings with the FDA / Chapter 5 : FDA medical device regulation / Chapter 6 : a primer of drug/device law : what is the law and how do I find it? / Chapter 7 : the development of orphan drugs / Chapter 8 : CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval stages / Chapter 9 : overview of the GxPs for the regulatory professional / Charpet 10 : FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Chapter 11 : the practice of regulatory affairs / Chapter 12 : FDA advisory committees / Chapter 13 : biologics / Cahpter 14 : regulation of combination products in the United States / Index. David S. Mantus and Douglas J. Pisano-- Josephine C. Babiarz and Douglas Pisano -- Michael R. Hamrell -- Charles Monahan and Josephine C. Babiarz -- Alberto Grignolo and Sally Choe -- Barry Sall -- Josephine C. Babiarz -- Scott N. Freeman -- Prabu Nambiar, Steven R. Koepke and Kevin Swiss -- Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- Karen L. Drake, Esq. -- David S. Mantus -- Christina A. McCarthy and David S. Mantus -- Florence Kaltovich -- John Barlow Weiner, Esq --
9781841849195(hardcover : acidfree paper) 9781841849195 1841849197(hardcover : acid-free paper)
2013047346
Drug development--United States.
United States. Food and Drug Administration --Rules and practice.
615.19 / MAN
Includes bibliographical references and index.
Preface / Editors -- Contributors -- Chapter 1 :overview of FDA and drug development / Chapter 2 : what is an IND? / Chapter 3 : the new drug application / Chapter 4 : meetings with the FDA / Chapter 5 : FDA medical device regulation / Chapter 6 : a primer of drug/device law : what is the law and how do I find it? / Chapter 7 : the development of orphan drugs / Chapter 8 : CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval stages / Chapter 9 : overview of the GxPs for the regulatory professional / Charpet 10 : FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Chapter 11 : the practice of regulatory affairs / Chapter 12 : FDA advisory committees / Chapter 13 : biologics / Cahpter 14 : regulation of combination products in the United States / Index. David S. Mantus and Douglas J. Pisano-- Josephine C. Babiarz and Douglas Pisano -- Michael R. Hamrell -- Charles Monahan and Josephine C. Babiarz -- Alberto Grignolo and Sally Choe -- Barry Sall -- Josephine C. Babiarz -- Scott N. Freeman -- Prabu Nambiar, Steven R. Koepke and Kevin Swiss -- Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- Karen L. Drake, Esq. -- David S. Mantus -- Christina A. McCarthy and David S. Mantus -- Florence Kaltovich -- John Barlow Weiner, Esq --
9781841849195(hardcover : acidfree paper) 9781841849195 1841849197(hardcover : acid-free paper)
2013047346
Drug development--United States.
United States. Food and Drug Administration --Rules and practice.
615.19 / MAN