Name: FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
Price: 642.51 NZD
Availability: InStock
Author: Pisano, Douglas J. ; Mantus, David S.
ISBN: 9781420073546

portada FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

Type

Physical Book

Publisher

CRC Press

Author

Pisano, Douglas J. ; Mantus, David S.

Language

English

Pages

464

Format

Hardcover

Dimensions

23.1 x 15.7 x 2.8 cm

Weight

0.77 kg.

ISBN

1420073540

ISBN13

9781420073546

Edition No.

0002

Synopsis "FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics"

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time information in a simple and concise format contains a chapter highlighting the new drug application (NDA) process discusses FDA inspection processes and enforcement options includes contributions from experts at companies such as Millennium and Genzyme, leading CRO's such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: clinical trial exemptions advisory committees provisions for fast track

Customers reviews

Have you read this book? Login to add your review.

More customer reviews

0% (0)
0% (0)
0% (0)
0% (0)
0% (0)

Questions and Answers about the Book

Do you have a question about the book? Login to be able to add your own question.

Opinions about Bookdelivery

More customer reviews

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics - Pisano, Douglas J. ; Mantus, David S.

Synopsis "FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics"

Customers reviews

Frequently Asked Questions about the Book

Is the book original?

In what language is the book written?

What is the format of this book?

Questions and Answers about the Book

Opinions about Bookdelivery