An edition of FDA regulatory affairs (2008)

FDA regulatory affairs

a guide for prescription drugs, medical devices, and biologics

2nd ed.

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  • 2 Want to read
Cover of: FDA regulatory affairs by Douglas J. Pisano
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Last edited by MARC Bot
December 26, 2022 | History
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An edition of FDA regulatory affairs (2008)

FDA regulatory affairs

a guide for prescription drugs, medical devices, and biologics

2nd ed.

by

  • 2 Want to read

This edition doesn't have a description yet. Can you add one?

Publish Date
Publisher
Informa Healthcare USA
Language
English

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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 Approval

Places

United States

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Edition Availability
Cover of: FDA regulatory affairs
FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics
2008, Informa Healthcare USA
in English - 2nd ed.
  • Not in Library
Libraries near you: WorldCat
Cover of: FDA Regulatory Affairs
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition
September 1, 2008, Informa Healthcare
Hardcover in English - 2 edition
Libraries near you: WorldCat
Cover of: FDA regulatory affairs
FDA regulatory affairs: a guide for prescription drugs, medical devices, and biologics
2008, Informa Healthcare USA
in English - 2nd ed.
Libraries near you: WorldCat

Add another edition?

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.

Published in
New York

Classifications

Dewey Decimal Class
615/.19
Library of Congress
RM301.25 .F37 2008

The Physical Object

Pagination
p. ;

ID Numbers

Open Library
OL18534682M
ISBN 10
1420073540
ISBN 13
9781420073546
LCCN
2008014296
Goodreads
3808052

Source records

Library of Congress MARC record
Library of Congress MARC record
Library of Congress MARC record
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December 26, 2022 Edited by MARC Bot import existing book
August 14, 2020 Edited by ImportBot import existing book
February 10, 2019 Created by MARC Bot import existing book