FDA Regulatory Affairs / edited by David Mantus and Douglas J.Pisano
Publication details: Boca Raton, FL : CRC Press, c2014. Edition: 3rd edDescription: xii, 387 p. : ill. ; 24 cmISBN: 9781841849195Subject(s): United States. Food and Drug Administration | Drug Approval--United States | United States Government Agencies-- United States | Biological Products--standards--United States | Equipment and Supplies--standards--United States | Government Regulation--United StatesDDC classification: 615.19 FDA| Item type | Current library | Home library | Call number | Status | Date due | Barcode | Item holds |
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English Lending
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Villa College QI Campus | Villa College Library | 615.19 FDA (Browse shelf(Opens below)) | Available | 17127 |
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Contents Include:
Chapter 1: Overview of FDA and Drug Development
Chapter 2: What is an IND?
Chapter 3: The new drug application
Chapter 4: Meeting with 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 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
Chapter 10: FDA regulation of the Advertising and Promotion
Chapter 11: The Practice and regulatory affairs
Chapter 12: FDA Advisory Committees
Chapter 13: Biologies
Chapter 14: Regulation of combination products in the United States
Includes bibliographical references and index.
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