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FDA Regulatory Affairs: A Guide for Prescription Dru...
US $78.99
ApproximatelyS$ 101.53
Condition:
Good
A book that has been read but is in good condition. Very minimal damage to the cover including scuff marks, but no holes or tears. The dust jacket for hard covers may not be included. Binding has minimal wear. The majority of pages are undamaged with minimal creasing or tearing, minimal pencil underlining of text, no highlighting of text, no writing in margins. No missing pages.
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Free USPS Media MailTM.
Located in: Montgomery Illinois, United States
Delivery:
Estimated between Tue, 12 Aug and Fri, 15 Aug to 91768
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30 days return. Seller pays for return shipping.
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eBay item number:316584176472
Item specifics
- Condition
- 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
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
Item description from the seller
Seller feedback (272,403)
- a***j (169)- Feedback left by buyer.Past monthVerified purchaseAwesome book! For a fast snail mail service, would shop again! A+++ Seller! Good condition and value. No issues with any appearances to show its quality.
- c***o (4475)- Feedback left by buyer.Past monthVerified purchaseBrilliant…not much more I can say. Thanks
- a***e (171)- Feedback left by buyer.Past monthVerified purchasePkg was shipped quite fast, my payment went quickly and smoothly. I received my tracking number as quickly as my payment went through. If I have to I would definitely and quickly deal with this store again. Everything went well and I have no problems at all with this eBay store. Thanks also this was a steal of a deal now. Thank youuu…
Seller feedback (272,403)
- a***j (169)- Feedback left by buyer.Past monthVerified purchaseAwesome book! For a fast snail mail service, would shop again! A+++ Seller! Good condition and value. No issues with any appearances to show its quality.
- c***o (4475)- Feedback left by buyer.Past monthVerified purchaseBrilliant…not much more I can say. Thanks
- a***e (171)- Feedback left by buyer.Past monthVerified purchasePkg was shipped quite fast, my payment went quickly and smoothly. I received my tracking number as quickly as my payment went through. If I have to I would definitely and quickly deal with this store again. Everything went well and I have no problems at all with this eBay store. Thanks also this was a steal of a deal now. Thank youuu…