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DSCSA’s Wholesale Drug Distributor and Third-Party Logistics Provider Regulations and Preemption of State Laws: Now Dancing on the “Floor” and the “Ceiling”

FDA Law

The FDA’s proposed licensing rule would implement a long-awaited provision of the 2013 Drug Supply Chain Security Act (“DSCSA”) that establishes the requirement for national license standards for WDDs and 3PLs. at least 2-3 years after the rule is finalized) the complicated current state and local license regimes continue.

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FDA Creates a New Advisory Committee for Genetic Metabolic Diseases – Could This Be an Opportunity to Support Rare Disease Product Development More Broadly?

FDA Law

GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” Note that FDA is currently soliciting applications to staff this committee.

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Improving Hospital Care for Older Adults through Acute Care for Elders (ACE Units): Kellie Flood and Stephanie Rogers

GeriPal

After coming out of residency and taking care of lots of complicated older adults as of now, a brand new physician attending, I really needed that team to help me out. Which patients are eligible to go to an ACE unit? What are the benefits of an ACE unit? If ACE units are so great, why are they not so common? . I think Kellie, do you have it?

Hospital 100
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Scope This! A Podcast on Gastroesophageal Reflux and Gastritis

PEMBlog

2013-0421 Tighe M, Afzal NA, Bevan A, et al. Red flags that you should always ask about include hematemesis, melana, dysphagia, and Unintentional weight loss, these all need further investigation for complications like esophagitis or another diagnosis such as EOE or peptic ulcer disease. J Pediatr Gastroenterol Nutr. doi: 10.1097/MPG.0000000000001889

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Aging and the ICU: Podcast with Lauren Ferrante and Julien Cobert

GeriPal

Alex: And we’re delighted to welcome you to the GeriPal Podcast, Julien Cobert, who is an intensivist and aging researcher GeriPal Podcast, Julien. Julien: Thanks Alex, thanks Eric. It’s great to be here. Eric: So we’re going to be talking about aging in the ICU. Chris Cornell is one of my favorite musicians. Alex: (Singing).

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What is Death? Winston Chiong and Sean Aas

GeriPal

Why does this issue keep coming up? Why is it unresolved? Today we put these questions to Winston Chiong, a neurologist and bioethicist, and Sean Aas, a philosopher and bioethicist. We’ll have a link to that in our show notes. We’re gonna double up on that subject. Alex 01:07 We haven’t figured it out. Alex 01:48 All right.

IT 113
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Going beyond the surface material: A podcast episode on cellulitis

PEMBlog

Camargo, Clinical Trial: Comparative Effectiveness of Cephalexin Plus Trimethoprim-Sulfamethoxazole Versus Cephalexin Alone for Treatment of Uncomplicated Cellulitis: A Randomized Controlled Trial, Clinical Infectious Diseases, Volume 56, Issue 12, 15 June 2013, Pages 1754–1762, [link] Liu C, Bayer A, Cosgrove SE, et al. What is it?

IT 59