TAG ARCHIVES FOR FDA

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

6
Feb2015

By Jim Gearhart, BA, Member of the Board of Directors for Quorum Review IRB

If one quote sums up the usefulness of PRIM&R’s annual Advancing Ethical Research (AER) Conference, I think it’s one I heard over the lunch table: "This is why you come to PRIM&R: to hear what’s coming up for the next year."
And I know I already used that line, in my last Blog Squad post from the 2014 AER Conference, but it came back to me again this week. Not even two months [...] Read more

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