| Document Type
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BL
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| Record Number
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642690
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| Doc. No
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dltt
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| Title & Author
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FDA regulatory affairs : : a guide for prescription drugs, medical devices, and biologics /\ edited by Douglas J. Pisano, David S. Mantus
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| Edition Statement
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2nd ed
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| Publication Statement
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New York :: Informa Healthcare USA,, c2008
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| Page. NO
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viii, 448 p. :: ill. ;; 24 cm
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| ISBN
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9781420073546 (hbk. : alk. paper)
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: 1420073540 (hbk. : alk. paper)
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| Bibliographies/Indexes
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Includes bibliographical references and index
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| Contents
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Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahé Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer
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| Subject
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United States.
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United States.
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| Subject
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Drug development-- United States
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Pharmaceutical industry-- United States
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Drug Industry-- standards
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United States Government Agencies
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Biological Products-- standards
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Equipment and Supplies-- standards
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Government Regulation
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United States
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| Dewey Classification
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615/.19
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| LC Classification
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RM301.25.F37 2008
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RM301.25.F37 2008
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| NLM classification
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QV 1F287 2008
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| Added Entry
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Pisano, Douglas J
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Mantus, David
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