FDA regulatory affairs / (Record no. 57914)

MARC details
000 -LEADER
fixed length control field 02279nam\a2200325\a\4500
001 - CONTROL NUMBER
control field 57914
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20260728100835.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 260728s2014 flu b 001 0 eng
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 978104116396
Qualifying information hardcover : acid-free paper
035 ## - SYSTEM CONTROL NUMBER
System control number (DNLM)101621073
040 ## - CATALOGING SOURCE
Original cataloging agency DNLM/DLC
Transcribing agency DLC
Description conventions rda
Modifying agency BD-DhIUB
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 61519
Edition number 23
Item number F287
245 00 - TITLE STATEMENT
Title FDA regulatory affairs /
Statement of responsibility, etc edited by David Mantus, Douglas J. Pisano.
250 ## - EDITION STATEMENT
Edition statement Third edition.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc UK:
Name of publisher, distributor, etc CRC Press/Taylor & Francis Group
Date of publication, distribution, etc 2024
300 ## - PHYSICAL DESCRIPTION
Extent xii, 387 pages ;
Dimensions 24 cm
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note 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.
526 ## - STUDY PROGRAM INFORMATION NOTE
School name Pharmacy
Department Pharmacy
Shelving Location Pharmacy Corner
541 ## - IMMEDIATE SOURCE OF ACQUISITION NOTE
Source of acquisition Trim Education
610 12 - SUBJECT ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element United States.
Subordinate unit Food and Drug Administration.
650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug Approval
Geographic subdivision United States.
650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element United States Government Agencies
Geographic subdivision United States.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Biological Products
General subdivision standards
Geographic subdivision United States.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Equipment and Supplies
General subdivision standards
Geographic subdivision United States.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Government Regulation
Geographic subdivision United States.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Mantus, David,
Relator term editor of compilation.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Pisano, Douglas J.,
Relator term editor of compilation.
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Dewey Decimal Classification
Koha item type Books
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Shelving location Date acquired Source of acquisition Cost, normal purchase price Serial Enumeration / chronology Total Checkouts Full call number Barcode Date last seen Copy number Cost, replacement price Price effective from Koha item type
    Dewey Decimal Classification     Library, Independent University, Bangladesh (IUB) Library, Independent University, Bangladesh (IUB) Pharmacy Corner 29/06/2026 Purchase 6000.00 2024   615.19 F287 030005 28/07/2026 01 12000.00 29/06/2026 Books
    Dewey Decimal Classification   Not For Loan Library, Independent University, Bangladesh (IUB) Library, Independent University, Bangladesh (IUB) Pharmacy Corner 29/06/2026 Purchase 6000.00 2024   615.19 F287 030006 28/07/2026 02 12000.00 29/06/2026 Books