Mantus, David editor of compilation. Pisano, Douglas J. editor of compilation. text bibliography flu UK CRC Press/Taylor & Francis Group 2024 2014 Third edition. monographic eng

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xii, 387 pages ; 24 cm 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. edited by David Mantus, Douglas J. Pisano. Includes bibliographical references and index. 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 61519 F287 978104116396 DNLM/DLC 260728 20260728100835.0 57914