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Case series of reports of pruritus and sipuleucel-T submitted to the Food and Drug Administration Adverse Event Reporting System

Published Online: 2019-12-19

Published Print: 2019-12

Authors

Dores, Graça M. https://orcid.org/0000-0002-3985-2935
Perez-Vilar, Silvia

Niu, Manette T.
License Information

Text and Data Mining valid from 2019-12-01

Version of Record valid from 2019-12-19
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Article History

Received: 29 September 2019

Accepted: 9 December 2019

First Online: 19 December 2019

Ethics approval and consent to participate

: FAERS is a legally mandated, government-sponsored surveillance system administered by FDA. This safety review is exempt from Institutional Review Board approval or informed consent because it meets criteria for exemption from the Office for Protection from Research Risks as specified in the Code of Federal Regulations:.

: Refer to “Ethics and approval and consent to participate” section above.

: The authors declare that they have no competing interests.

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