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Ther Innov Regul Sci. 2021 Jul;55(4):705-716. doi: 10.1007/s43441-021-00268-x. Epub 2021 Mar 17.
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PMID: 33730364
Review.
A sponsor must file an IND safety report for any serious unexpected suspected adverse reaction (SUSAR) of a medicinal product being investigated. Some events may be obviously drug-related (e.g., agranulocytosis, anaphylactic reaction, drug-induced hepatic injury, Stevens-J …
A sponsor must file an IND safety report for any serious unexpected suspected adverse reaction (SUSAR) of a medicinal product being investig …