FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning.

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Common Sense Family Doctor

MAY 30, 2025

The US Preventive Services Task Force , the American Academy of Family Physicians , and the American College of Chest Physicians recommend annual low-dose computed tomography (CT) screening for adults 50 to 80 years of age who have at least a 20 pack-year smoking history and currently smoke or have smoked within the past 15 years.

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Medical Xpress

JUNE 16, 2025

But experts say the risks can be lowered through heart screenings, close monitoring and giving magnesium before and during treatment, The Times added in its report. The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA).

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The Clinical Problem Solvers

MARCH 4, 2024

She discovered narrative medicine, and to her, it was about finding and retelling individual and structural stories in antiracist ways. Listening to individual stories within the context of their structural stories is important. Sayantani became a physician since she thought it was a concrete tool for social justice.

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Vida Family Medicine

APRIL 27, 2023

Insufficient Sleep Window : One of the most common situations that I see is that individuals are not allowing themselves an adequate time period for sleep. These individuals may also suffer from one or both of the types of insomnia listed below, which further decreases their total sleep time.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Screening for substance use and offering connections to treatment and community-based services are important strategies that clinicians can implement in their own practice today. Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group.

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GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. Is it you Lyndsay?

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GeriPal

FEBRUARY 8, 2024

Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. 2023 Dec 20:S1524-9042(23)00202-3. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004. Epub ahead of print. PMID: 38129210. Kleinman, A. The illness narratives suffering, healing, and the human condition. Naomi: Yes, I do. Everybody Hurts by REM. Alex: Yeah.

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GeriPal

FEBRUARY 20, 2025

We also explored several questions with them, including how to define trauma, its prevalence in older adults, the impact of past traumatic experiences, the potential triggers of trauma screening, and the application of trauma-informed principles in clinical practice. Mariah, welcome to the GeriPal Podcast. Mariah 00:29 Glad to be here.

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Medical Xpress

JUNE 8, 2025

Sucrose is thought to activate centers of the brain that modulate pain and lead to the release of endorphins , but the exact mechanism remains unclear. It has become the worldwide standard of care for acute neonatal pain, but it doesnt seem to be helping in the long term. Read the original article.

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FDA Law Blog

JULY 9, 2024

Where sponsors plan to conduct several clinical studies that may be subject to DAP requirements, the plan for each study should reflect a strategy that leads to an overall proportionate representation, even though individual studies may not. population demographics. population demographics.

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Clinic Provider Individual IT 59

GeriPal

FEBRUARY 13, 2025

And so we worked closely with a community advisory group who, through focus groups, told us how it was that black and white individuals with serious illness had wanted to be treated. Another interpretation is that clinicians avoided telling the parents prognosis in order to bolster their ratings of trust and communication quality.

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GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US.

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GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Malaz: I love it.

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Patient-Centered IT Family Families 125

Medical Xpress

JUNE 8, 2025

The research, published this week in Safety Science , collected data from 562 recreational surfers from 2020 to 2023. Although they make a vital contribution to saving lives, bystander rescues often expose untrained individuals to hazardous conditions without the training and equipment available to professionals. times, first aid 0.4

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GeriPal

JUNE 2, 2022

So take a listen and if you want a deeper dive into some of the references we discuss on the podcast, here is a list: Medscape article on how “ COVID-19 Vaccines Work Better and for Longer Than Expected Across Populations, Including Immunocompromised Individuals”. Stat news article about variants/COVID becoming more predictable. Alex: Great.

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GeriPal

JULY 16, 2024

We talk about positive aspects of aging, cognitive screening, the line between legitimate concerns and ageism, ableism, advice for a geriatrician asked to comment on TV, frailty and physical disability, images in the press , historical situations including , and an upper age limit for the Presidency, among other issues. Ken 02:33 Bravo.

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