Managing the Risks of Medicines: An Examination of FDA's Application of Criteria for Requiring a REMS.
Title: | Managing the Risks of Medicines: An Examination of FDA's Application of Criteria for Requiring a REMS. |
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Authors: | Seligman, Paul J., Anguiano, Rebekah H., Felix, Thomas, Stabi, Katie |
Source: | Therapeutic Innovation & Regulatory Science; Jul2019, Vol. 53 Issue 4, p542-548, 7p |
Database: | Complementary Index |
ISSN: | 21684790 |
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DOI: | 10.1177/2168479018791560 |
Published in: | Therapeutic Innovation & Regulatory Science |
Language: | English |