October 31, 2019 09:50 AM EDT

FDA to require certain IND safety reports be submitted to FAERS

Michael Mezher

The FDA on Tuesday issued draft guidance requiring sponsors to submit investigational new drug (IND) safety reports for serious and unexpected suspected adverse events …

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FDA to require certain IND safety reports be submitted to FAERS

Michael Mezher

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FDA to re­quire cer­tain IND safe­ty re­ports be sub­mit­ted to FAERS

Michael Mezher

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