FDA regulatory affairs : a guide for prescription drugs, medical devices, and biologics / edited by Douglas J. Pisano, David S. Mantus.

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 co...

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Bibliographic Details
Online Access: Full Text (via Taylor & Francis)
Other Authors: Pisano, Douglas J., Mantus, David
Format: eBook
Published: New York : Informa Healthcare USA, ©2008.
Edition:2nd ed.


Full Text (via Taylor & Francis)


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Call Number: RM301.25 .F37 2008eb
RM301.25 .F37 2008eb Available