The US Food and Drug Administration (FDA) last week issued draft guidance offering insights to sponsors and institutional review boards (IRBs) on the process for referring research involving children ...
All human subjects research connected with members of the Smith College community (either as researchers or study participants) must be reviewed and approved by the IRB prior to the initiation of the ...
To comply with the 21st Century Cures Act, 1 the Food and Drug Administration (FDA) has released two Notices of Proposed Rulemaking (NPRMs). NPRMs are the initial public notice of a proposed change to ...