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Oregon-based medical group Northwest Permanente announces affiliation with The Permanente Medical Group of Northern California

Permanente Medicine

Both groups have a shared mission of delivering high-quality, cost-efficient care that achieves superior clinical outcomes. By collaborating clinically, sharing innovations, and supporting physicians and staff, NWP will improve quality of care. Kaiser Permanente in Northern California received 4.5

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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.

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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. By David B. Clissold & Sara W.

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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

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Demystifying the Role of HHS and ASPE in Guiding Federal Aging Policy and Priorities with Dr. Tisamarie Sherry

GeriPal

For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. And so there was a report in 2009 by the Institute of Medicine saying that we need to equip all of these individuals in caring for older person in an evidence based manner. We talk about: . So you’re right.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

This long and sordid history of gabapentin and pregabalin is beautifully described in Seth Landefeld and Mike Steinman 2009 NEJM editorial. I understand that it can be a hard place clinically. We should be able to trust all the data that comes from our governing board. Cochrane Database of Systematic Reviews Review.

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Is Hospice Losing Its Way: A Podcast with Ira Byock and Joseph Shega

GeriPal

Full disclosure, I talked with Ava Kofman a bunch while she was preparing that article, and I thought based on my professional experience working in hospice, things that I had seen, that she raised a lot of issues that I had personally encountered in my clinical experience. singing) Ira: Thank you very much.

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