TAG ARCHIVES FOR FDA

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for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations.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

10
Nov2015

On May 14, PRIM&R hosted a webinar titled IRB Oversight and FDA Review of Studies that Include In-Vitro Diagnostics (IVDs), presented by Jonathan M. Green, MD, professor of medicine, pathology, and immunology, associate dean for human studies, and executive chair of the institutional review board (IRB) at Washington University School of Medicine in St. Louis, MO, and E. David Litwack, PhD, personalized medicine staff at the Office of In Vitro Diagnostics and Radiological Health at the US Food and Drug Administration (FDA).

At the conclusion of the webinar, Dr. Green and Dr. Litwack shared additional insight in response to questions from webinar attendees, and [...] Read more

19
Jun2015

Traditional research methodologies are being used to address a number of longstanding challenges, including how to make health care more efficient and effective, and how to fight poverty. This week’s Research Ethics Roundup sheds light on the role of research in answering those questions, as well as other stories related to research ethics and oversight.


Don’t Weaken the FDA’s Drug Approval Process
: The 21st Century Cures Act proposes significant changes to the approval process for many medical products. In this opinion piece for The New York Times, Gregg Gonsalves, Mark Harington, and David A. Kessler warn that “Congress should [...] Read more

27
Feb2015

This week’s Research Ethics Roundup highlights ethical issues related to clinical trials studying the psychedelics, as well as moves toward making research more efficient, innovative, and transparent.

The Trip Treatment: Author and journalist Michael Pollan reports on the reemergence of research on psychedelics. In this article from The New Yorker, Pollan shares stories of participants and their experiences in clinical trials studying the psychedelic psilocybin.

Clinical-Trial Specialist Could Be Next FDA Chief: In this article from Nature, journalist Heidi Ledford provides background on Robert Califf, who was recently [...] Read more

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