TAG ARCHIVES FOR FDA

16
Dec2016

This week’s Research Ethics Roundup examines new international guidelines that focus on research in low-and middle-income countries, experts’ unease over increasing changes to the FDA’s mission, the academic debate over primate research, and what 21st Century Cures means for public health. Read more

2
Dec2016

This week’s Research Ethics Roundup reviews researchers’ efforts to learn about how traumatic brain injury affects women’s brains, the first CRISPR gene-editing human subjects trial, why patient groups object to changing FDA rules on off-label promotion, and scientists’ arguments for why living conditions for lab mice need to change.

brainWanted: Women’s Brains — to Jump-Start Lagging Research on Female Concussions: In this STAT News article, Usha Lee McFarling examines new efforts to collect data on the effects of traumatic injury on women’s [...] Read more

7
Oct2016

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for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more

12
Aug2016

On August 2, 2016, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on institutional review board (IRB) written procedures. The guidance is “intended for…IRBs and institutions responsible for review and oversight of human subject research under the HHS or FDA regulations, or both.” Read more

11
Aug2016

In Case You Missed It (ICYMI): From time-to-time, PRIM&R will feature particularly well-received posts from the recent past.  These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, PRIM&R Executive Director Elisa Hurley explores the complex issue of clinical trial data sharing and its implications for the protection of human research subjects.

Though not a new issue, clinical trial data sharing has over the past several months taken center stage within the medical research community. In December 2015, a STAT Read more

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