TAG ARCHIVES FOR FDA

30
Dec2016

This week’s Research Ethics Roundup examines what the new 21st Century Cures law means for harmonization efforts, why cancer trials struggle with minority enrollment, a new study on reporting of bias-reducing methodologies in animal research, and the argument for open access publishing.   

Cures Law Requires FDA, HHS to Harmonize Regs
Jeannie Baumann reports for Bloomberg BNA about a provision in the new 21st Century Cures law that requires the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) to address any differences between their corresponding [...] Read more

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for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on institutional review board (IRB) written procedures.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(DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance on institutional review board (IRB) written procedures.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

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