FDA regulatory affairs / edited by David Mantus, Douglas J. Pisano.Material type: TextPublisher: Boca Raton, FL : CRC Press, Taylor & Francis Group, Edition: Third editionDescription: xii, 387 pages ; 24 cmContent type: text Media type: unmediated Carrier type: volumeISBN: 9781841849195 (hardcover : acidfree paper)Subject(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 LOC classification: RM301.25 | .F37 2014NLM classification: QV 771
Includes bibliographical references and index.
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.