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Subjects
Drug Industry, United States Government Agencies, Drug development, United States Food and Drug Administration, Biological Products, Standards, Pharmaceutical industry, Equipment and Supplies, Rules and practice, United States, Government Regulation, United States. Food and Drug Administration, Drugs, design, United states, food and drug administration, Drug ApprovalPlaces
United StatesShowing 3 featured editions. View all 3 editions?
Edition | Availability |
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1
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition
September 1, 2008, Informa Healthcare
Hardcover
in English
- 2 edition
1420073540 9781420073546
|
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Libraries near you:
WorldCat
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2
FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics
2008, Informa Healthcare USA
in English
- 2nd ed.
1420073540 9781420073546
|
zzzz
Libraries near you:
WorldCat
|
3
FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics
2008, Informa Healthcare USA
in English
- 2nd ed.
1420073540 9781420073546
|
aaaa
Libraries near you:
WorldCat
|
Book Details
Table of Contents
Overview of drug development and the FDA / Josephine Babiarz
IND / Michael R. Hamrell
Formatting, assembling, and submitting a CTD (NDA) / Charles Monahan III
Meeting with the FDA / Alberto Grignolo
Biologics / J. Kenimer
FDA medical device regulation / Barry Sall
The development of orphan drugs / Tan Nguyen
Combination products / Tara Dunn
Chemistry, manufacturing, and control issues: drugs and biologics / Prabu Nambiar
Good clinical practices, good manufacturing practices, and good laboratory practices / Robert Buckley
The regulation of promotional materials and advertising for drugs / Karen Drake
CTD submissions: a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, Vah Ghahraman
The practice of regulatory affairs / Dave Mantus
A primer of drug/device law or what's the law and how do I find it? / Josephine Babiarz
Advisory committee system at FDA / Christina McCarthy.
Edition Notes
Includes bibliographical references and index.
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- Created November 3, 2008
- 5 revisions
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July 31, 2019 | Edited by MARC Bot | associate edition with work OL18661575W |
April 24, 2010 | Edited by Open Library Bot | Fixed duplicate goodreads IDs. |
April 16, 2010 | Edited by bgimpertBot | Added goodreads ID. |
April 13, 2010 | Edited by Open Library Bot | Linked existing covers to the edition. |
November 3, 2008 | Created by ImportBot | Imported from Library of Congress MARC record |