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US $78.99
Approximately£58.37
Condition:
Good
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eBay item number:316584176472
Last updated on 14 Jun, 2025 06:24:25 BSTView all revisionsView all revisions

Item specifics

Condition
Good: A book that has been read, but is in good condition. Minimal damage to the book cover eg. ...
Book Title
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medica...
ISBN
1587160072
EAN
9781587160073
Release Title
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medica...
Artist
various
Brand
N/A
Colour
N/A

About this product

Product Identifiers

Publisher
CRC Press LLC
ISBN-10
1587160072
ISBN-13
9781587160073
eBay Product ID (ePID)
2819205

Product Key Features

Number of Pages
360 Pages
Publication Name
Fda Regulatory Affairs : a Guide for Prescription Drugs, Medical Devices and Biologics
Language
English
Publication Year
2003
Subject
Industries / Pharmaceutical & Biotechnology, Pharmacology, American Government / National
Type
Textbook
Author
David Mantus
Subject Area
Political Science, Business & Economics, Medical
Format
Hardcover

Dimensions

Item Height
1 in
Item Weight
18.4 Oz
Item Length
0.9 in
Item Width
0.6 in

Additional Product Features

Intended Audience
Scholarly & Professional
LCCN
2003-055779
Dewey Edition
22
Illustrated
Yes
Dewey Decimal
615/.19/00973
Synopsis
This book covers the regulatory process for getting pharmaceuticals, biologics, and medical devices approved. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. Topics include: the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System Compliance and the corresponding documentation requirements, and FDA inspection processes and enforcement options. Although many references exist on this subject, this one is written in a general prose style that makes it useful to both students and professionals., Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the myriad and sometimes confusing regulations that govern this constantly changing field. The book examines the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human drug and device development, research, manufacturing, and marketing. It focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements. Although there are a number of references on these topics, this book is unique in that it is written in a general, easy to read prose style. It presents information drawn from a wide range of resources in a single, easy to use format. FDA approval can be a lengthy and expensive process. In order for a pharmaceutical manufacturer to place a product on the market for human use, a multiphase procedure must be followed. Providing a reference for students, professionals, and especially those who are charged with the day-to-day tasks of assuring regulatory compliance under FDA guidelines, this book demystifies the inner workings of the FDA and allows you to understand how it operates with respect to product approval.
LC Classification Number
RM301.27

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