FDA Law Blog

DECEMBER 1, 2024

Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.” Then along came the FDA Safety and Innovation Act (“FDASIA”) (our firm’s summary of the law, which was enacted in 2012, is here ). 331(f)).

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Noreta Family Medicine

FEBRUARY 12, 2025

An Escape Fire for Healthcare I recently watched a film, called “ Escape Fire: The Fight to Rescue American Healthcare, ” a 2012 documentary about how the priorities in the US healthcare system are focused on increasing revenue, instead of on goals that improve health, like preventive care.

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FDA Law Blog

MARCH 1, 2023

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

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FDA Law Blog

DECEMBER 4, 2023

12, 2012). “[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a ‘reasonable professional,’ there is a duty to question the prescription.” Immediate Release Opioids A prescription for immediate release (“IR”) opioids on a set schedule or for a certain length of time. Complaint ¶ 64.

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The Clinical Problem Solvers

APRIL 24, 2025

The episode also explores how digital tools can help youth manage their mental health, while also noting the need for culturally relevant care providers. Suicide Trends Among Elementary School-Aged Children in the United States From 1993 to 2012. JAMA Netw Open. 2020;3(8):e2013100. doi:10.1001/jamanetworkopen.2020.13100 2020.13100 6.

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PEMBlog

MAY 1, 2025

Youll also learn how to manage exposures in the emergency department, especially when the child has a pregnant caregiver, and why isolation isnt always necessary once the rash shows up. Management of erythema infectiosum is supportive care onlyantipyretics, hydration, and reassurance. So how do we diagnose Parvovirus B19?

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Complication Patient-Centered Patients Clinic 83

FDA Law Blog

FEBRUARY 21, 2022

Dr. Unger transitioned to the Office of Drug Evaluation-I in 2009, and became its Director in 2012. His experience at FDA and insights into the FDA approval process broaden and strengthen our capabilities in ways that will benefit our clients,” said JP Ellison, HP&M’s Managing Director.

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Common Sense Family Doctor

FEBRUARY 1, 2025

Recognizing their potential to save money and improve outcomes, in 2013 the Centers for Medicare and Medicaid Services began allowing practices to bill separately for transitional care management (TCM) services that included an interactive contact within two business days of discharge and a dedicated face-to-face office visit within 14 days.

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Hospital Management Primary Care Primary Care Physician 52

Common Sense Family Doctor

MAY 11, 2025

A recent article in the BMJ summarized a National Institute for Health and Care Excellence (NICE) guideline on identification and management of gambling-related harms. Although prevalence estimates in North America are low (1.5% of women, 2.7%

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Management Referral Mental Health Community 52

Common Sense Family Doctor

DECEMBER 4, 2024

A recent editorial in the Journal of the American Heart Association discussed a “paradigm shift” in management of severe aortic stenosis: 69% of Medicare fee-for-service beneficiaries who underwent aortic valve replacement from 2012-2019 had TAVI, with the percentage undergoing SAVR falling from 75% in 2012 to just 10% in 2019.

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Hospital Management Patients Clinic 52

PEMBlog

MAY 24, 2023

This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate non pharmacologic management strategies for agitated children. 2012 Jan;109(3):27-32. 2012 Feb;13(1):35-40. The combative multitrauma patient: a protocol for prehospital management.

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Management Patient-Centered Physicals Finance 54

Physician's Weekly

JUNE 19, 2025

Data came from the three influenza seasons from 2012 to 2015. Incorporating Frailty in RSV Management The findings demonstrate that frailty represents “a significant factor influencing adverse outcomes in older adults hospitalized with RSV infection ,” Dr. Andrew and colleagues wrote. “The

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Illness Hospital Patients Management 52

PEMBlog

JUNE 2, 2025

Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. Management of Hypertensive Crises in Children: A Review of the Recent Literature. 2012 Sep 5;4:85-92. Front Pediatr. 2022;10:880678. Published 2022 Apr 15.

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Permanente Medicine

APRIL 29, 2025

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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Screening Checkup Integrated Care Electronics 52

FDA Law Blog

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. There was this big thing called the CMS National Partnership to Improve Dementia Care, started in 2012. Now that we are in this position, when I think about data for pain management specifically, I feel like yes, there’s value to it.

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FDA Law Blog

FEBRUARY 9, 2022

12, 2012) (quoting Bob’s Pharmacy & Diabetic Supplies; Revocation of Registration, 74 Fed. Improper Dosing for Pain Management. Holiday CVS, L.L.C. d/b/a CVS/Pharmacy Nos. 219 and 5195; Decision and Order , 77 Fed. 62,316, 62,341 (Oct. 19,599, 19,601 (Apr. 29, 2009)). at 72,730.

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PEMBlog

DECEMBER 14, 2023

Learn all about diagnosis and management of this common problem in this brief podcast episode. 2012 Oct;147(4):619-26. So this management is conservative, includes upright feeding, antireflux therapy, so alterations to how you Feed, burp, and position. Treasure Island (FL): StatPearls Publishing; 2023 Jan-.

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Diagnosis IT Diagnose Patients 52

PEMBlog

APRIL 26, 2023

Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., Healthcare providers need to be aware of and manage their biases concerning this topic, and that starts by ensuring that we ask all families about it. Melzer-Lange, Joseph O’Neil, Wendy J. Pomerantz, Elizabeth C. Powell, Seth J. Scholer, Gary A. 10.1542/peds.2012-2481

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PEMBlog

JUNE 5, 2024

2012 Jan 13;61(RR-1):1-20. Let’s go ahead and pivot to initial management. So they have Posterior midline neck pain, altered mental status, but a GCS of greater than 8, or some substantial comorbid head or thoracic injury that requires management or admission to the hospital. MMWR Recomm Rep. PMID: 22237112.

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Patient-Centered Patients IT Hospital 52

GeriPal

FEBRUARY 2, 2024

Going back to when I was shopping this idea around the health systems in 2012, we landed on the stepped-wedge design because no one was… I said before you couldn’t randomize people to get palliative care or not, specifically. Eric: And this was done pre-COVID, right? Scott: This was, yes. This was a lifetime’s worth of work.

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Consulting Hospital Patient-Centered IT 122

GeriPal

MARCH 7, 2024

There’s an organization that I took my training from, which began, I want to say, in 2012. Healthcare, just the way healthcare is structured, that’s not something that’s feasible unless there’s a specific symptom management need that allows for more care, but just to provide simple care doesn’t exist.

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GeriPal

MARCH 20, 2025

And she was from Oregon, of course, and in Oregon in 2012, she had completed an advanced directive for stopping eating and drinking once she had advanced dementia. Thaddeus 39:58 That’s how she decided to manage it. And I knew it was a matter of time before this came along. Is that right, Hope? Eric 39:56 Oh, you’re saying.

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IT Patient-Centered Patients Medical 89

GeriPal

AUGUST 1, 2024

But at any age, like, as Emily said, it is so important to pay attention to nutrition and healthy eating because it’s not just about, oh, chronic disease prevention or even treatment and management. You feel better in the moment, so it doesn’t matter how old you are, feeling good helps you have a better quality of life.

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IT Diabetes Chronic Disease Patient-Centered 118

Physician's Weekly

JUNE 25, 2025

Scientists had developed powerful HIV drugs that, if taken daily, transform it from a death sentence into a manageable chronic disease in which a person’s virus levels are so suppressed that they cannot spread HIV to others. .’” Once he regained his health, Sturdevant resolved to care for others in his position.

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GeriPal

APRIL 17, 2025

Eric 10:04 And how many Major League managers are. So that Jackie Robinson had hoped to become a manager after he left baseball. And in his hall of Fame speech, he called for the day where there would be black managers in baseball. So basically the two best managers in baseball. Eric 10:50 Yeah.

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IT Community Government Management 71

Physicians News Digest

APRIL 3, 2025

He and Harvard colleague Celeste Royce have sued AHRQ, HHS , and the Office of Personnel Management over removal of the article. Cases of jaundice-related brain damage declined from 7 per 100,000 to about 2 per 100,000 newborns from 1997 to 2012. Schiff was offered the option of removing the LGBTQ reference but refused.

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