Status of FDA postapproval studies.
In: Reactions Weekly, Jg. 1672 (2017-10-07), Heft 1, S. 12-12
Online
serialPeriodical
Zugriff:
The article offers information on a study published in the periodical " New England Journal of Medicine (NEJM)" on the accelerated drug availability processes in the U.S. requiring phase IV post-approval studies to be conducted and mentions the 2007 U.S. Food and Drug Administration (FDA) Amendments Act (FDAAA). Topics discussed include FDA drug approval, drugs' safety and efficacy issues, and requirement for a drug manufacturer to perform a post-approval study.
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Status of FDA postapproval studies.
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Zeitschrift: | Reactions Weekly, Jg. 1672 (2017-10-07), Heft 1, S. 12-12 |
Veröffentlichung: | 2017 |
Medientyp: | serialPeriodical |
ISSN: | 0114-9954 (print) |
DOI: | 10.1007/s40278-017-36829-2 |
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