TAG ARCHIVES FOR FDA

13
May2016

This week’s Research Ethics Roundup focuses on the ethical arguments for conducting Zika research on pregnant women, Public Citizen’s challenge of the Food and Drug Administration's (FDA's) redaction policy, and the official investigation on why a phase I trial in France left one dead. (more…) Read more

4
Feb2016

PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. Read more

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