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eMDR System Enhancements

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. They also review CSOS transactions for completeness and accuracy.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K. They also review CSOS transactions for completeness and accuracy.

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Time to stop driving? Podcast with Emmy Betz and Terri Cassidy

GeriPal

That’s where it really gets to this individual risks and balances, individual situation. So just starting to unpack what’s happening in an individual’s life can maybe then lead to more conversations and assessment. I think it was 2014, but we did a survey of driving rehabilitation specialists in the U.S.

Families 102
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Sweet! A Metabolic Disorders focused podcast episode

PEMBlog

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. References Jeanmonod R, Asuka E, Jeanmonod D.

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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

Corita 09:39 Yeah, so we used the electronic health record, I think, in support. And so we did a similar intervention but using electronic means. Eric 26:01 Curtis’s, he had a 2014 JAMA article on simulation. You’d have to tailor it to each individual emergency department because you couldn’t.

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RCT of Chaplaincy: Lexy Torke, Karen Steinhauser, LaVera Crawley

GeriPal

Lexy: Yeah, so I can say that I became about, in 2014, I had the opportunity to lead a center at our health system called the Evans Center that focuses on religion, spirituality, and health. We randomized individual patients either to the SKY framework or to usual care. I don’t see a lot of those out there. Lexy: Yeah.

IT 99