Please use this identifier to cite or link to this item:
https://erepository.fmesinstitute.org/handle/123456789/1709
Title: | FDA Regulation of prescription drugs. |
Authors: | Gassman, A. L. Nguyen, C. P. Joffe, H. V. |
Issue Date: | 2017 |
Publisher: | New England Journal of Medicine |
Citation: | Gassman, A. L., Nguyen, C. P., & Joffe, H. V. (2017). FDA Regulation of prescription drugs. New England Journal of Medicine, 376(7), 674–682. |
Abstract: | Over the past 5 years, the FDA has approved 182 new drugs. This overview explains the FDA’s drug-approval process, including its approach to benefit–risk assessment, drug labeling, risk evaluation and mitigation strategies, and postmarketing surveillance. |
URI: | https://doi.org/10.1056/NEJMra1602972 https://erepository.fmesinstitute.org/handle/123456789/1709 |
metadata.fmes.numPages: | 674–682 |
Appears in Collections: | Ethics |
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