2016 IT Management Specialization 
PEMBlog
JUNE 14, 2023
Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Children’s Mental Health Emergency Department Visits: 2007-2016. It is also the final episode in a 5 episode series focused on agitation in children and adolescents. 2021;147(5):e2020030692. doi: 10.1542/peds.2020-030692
FDA Law Blog
APRIL 25, 2023
Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device. Special 510(k)s. This provision became effective as of March 29, 2023. It applies whether the software is the entire device (i.e.,
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The Clinical Problem Solvers
DECEMBER 16, 2020
Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”
FDA Law Blog
FEBRUARY 22, 2023
as a de novo special control or in a guidance document for a specific device type). By Jeffrey K. Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. Industry would certainly welcome guidance intended to smooth the HF aspects of 510(k) reviews.
FDA Law Blog
NOVEMBER 20, 2024
Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.
GeriPal
OCTOBER 10, 2024
Show me your scars.” Scars, really? I’ve been there. You probably have too. On the one hand, I don’t think interprofessional teamwork needs to be scarring. On the other hand, though it goes against my middle-child “can’t we all get along” nature, disagreement is a key aspect of high functioning teams. Alex 02:38 Love it.
GeriPal
APRIL 14, 2022
Management of chronic pain in the elderly: focus on transdermal buprenorphine. We got some really special guests with us. So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. But does this drug really live up to the hype? Transcript.
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