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Fda Regulatory Affairs A Guide For Prescription Drugs Medical Devices And Biologics 1st Edition Douglas J Pisano

Name: Fda Regulatory Affairs A Guide For Prescription Drugs Medical Devices And Biologics 1st Edition Douglas J Pisano
SKU: BELL-1126828
Price: 31.00 USD
Availability: InStock
Rating: 4.1 (20 reviews)

SKU: BELL-1126828

$ 31.00 ~~$ 45.00~~ (-31%)

4.1

20 reviews

Fda Regulatory Affairs A Guide For Prescription Drugs Medical Devices And Biologics 1st Edition Douglas J Pisano instant download after payment.

Publisher: Informa Healthcare

File Extension: PDF

File size: 7.55 MB

Pages: 466

Author: Douglas J. Pisano, David Mantus

ISBN: 9781587160073, 1587160072

Language: English

Year: 2003

Edition: 1

Product desciption

Fda Regulatory Affairs A Guide For Prescription Drugs Medical Devices And Biologics 1st Edition Douglas J Pisano by Douglas J. Pisano, David Mantus 9781587160073, 1587160072 instant download after payment.

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