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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| Online Access: |
Full Text (via Taylor & Francis) |
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| Other Authors: | , |
| Format: | eBook |
| Language: | English |
| Published: |
New York :
Informa Healthcare USA,
©2008.
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| Edition: | 2nd ed. |
| Subjects: |
Internet
Full Text (via Taylor & Francis)Online
| Call Number: |
RM301.25 .F37 2008eb
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| RM301.25 .F37 2008eb | Available |