02279nam\a2200325\a\4500 57914 20260728100835.0 260728s2014 flu b 001 0 eng 978104116396 hardcover : acid-free paper (DNLM)101621073 DNLM/DLC DLC rda BD-DhIUB 61519 23 F287 FDA regulatory affairs / edited by David Mantus, Douglas J. Pisano. Third edition. UK: CRC Press/Taylor & Francis Group 2024 xii, 387 pages ; 24 cm 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. PHR phr PHAR TRIM 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 States. Mantus, David, editor of compilation. Pisano, Douglas J., editor of compilation. ddc BK 57914 58088 0 0 ddc 0 0 IUBL IUBL PHAR 2026-06-29 PURCHASE 6000.00 2024 0 615.19 F287 030005 2026-07-28 10:10:00 01 12000.00 2026-06-29 BK 0 0 ddc 0 1 IUBL IUBL PHAR 2026-06-29 PURCHASE 6000.00 2024 0 615.19 F287 030006 2026-07-28 10:10:00 02 12000.00 2026-06-29 BK