FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Day 90 FDA sends final MDUFA Decision on 510(k).

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FDA Law Blog

MAY 17, 2022

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s And UFA reauthorization provides the perfect vehicle for the Agency to try and get this accomplished. In it, FDA provides a brief overview of the Eleventh Circuit’s decision. and more likely 15-20. and Peter Marks, M.D.,

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Annals of Family Medicine

NOVEMBER 20, 2024

A US-based study conducted by the Kaiser Family Foundation found 69% of patients reported avoiding discussions about death, but 92% reported feeling somewhat comfortable talking to a heath care provider about EOL wishes. Setting or Dataset: Outpatient palliative care cancer clinic at a tertiary health care center in the U.S.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. A more Western perspective on health care emphasizes the role of physicians and health care providers and marginalizes the role and contributions of doulas and midwives.

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My Green Doctor

MAY 29, 2025

Urging healthcare professionals to educate their patients on these topics and all related sustainability and resilience action steps. Investing in climate-smart healthcare infrastructure—clinics that can withstand extreme heat, storms, and flooding. Working on a Warmer Planet (2019). Link NRDC/Medical Society Consortium.

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The Clinical Problem Solvers

APRIL 5, 2022

Dr. Kushel and Mr. Watts remind healthcare providers to speak out about the structural causes of homelessness. Published April 5, 2019. January 18, 2019. The Clinical Problem Solvers Podcast. This episode was hosted by Sudarshan Krishnamurthy, Jazzmin Williams, and Alec Calac. Can you refer your patient there? 3.

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BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. For healthcare providers, there should be a recognition that holistic care involves more than just prescribing medications.

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GeriPal

MAY 18, 2023

Alex: And we’re delighted to welcome Todd Semla, who is a clinical pharmacist and associate professor at the Feinberg School of Medicine at Northwestern University. Mike: 2019. Eric: 2019. But it does kind of provide that caution, it kind of slows things down to make sure you’re really paying attention.

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GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. Sach Kale set up an outpatient clinic focused on substance use disorder for patients with cancer. Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). What do they do?

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GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. I’m part of a clinical trial that’s housed at the Lundquist Institute down at Harbor-UCLA.

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GeriPal

APRIL 13, 2023

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers.

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. James 00:32 Good afternoon.

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Illness IT Patient-Centered Patients 107

GeriPal

MARCH 24, 2023

Full disclosure, I talked with Ava Kofman a bunch while she was preparing that article, and I thought based on my professional experience working in hospice, things that I had seen, that she raised a lot of issues that I had personally encountered in my clinical experience. She happened to focus on some specific for-profit hospice providers.

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GeriPal

NOVEMBER 2, 2023

So a couple weeks after it was published, I took a trip to a medical school in the western part of the country and I was visiting to think about their geriatrics research program, and they had a geriatrics evaluation clinic. And I met with the clinical pharmacist who worked in that clinic and she told me, “You know what?

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Medical Xpress

JUNE 8, 2025

While many of these procedures provide critical care, we know they are acutely painful. Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. The content is provided for information purposes only. Read the original article.

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PEMBlog

APRIL 26, 2023

Listen Gun Violence and Safety (2023) – Brad Sobolewski, MD, MEd – featuring Kit Carney, MD & Kristen Humphrey, MD – PEM Currents: The Pediatric Emergency Medicine Podcast [link] Subscribe Advocacy and education resources Be SMART Campaign Be SMART emphasizes the importance of responsible gun ownership and secure gun storage.

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GeriPal

APRIL 26, 2024

ELNEC (End-of-Life Nursing Education Consortium) celebrates it’s 25th anniversary in 2025. Some numbers to back it up: ELNEC has trained more than 48,000 providers in a train the trainer model Over 1.5 Some numbers to back it up: ELNEC has trained more than 48,000 providers in a train the trainer model Over 1.5 Doing home care?

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GeriPal

APRIL 11, 2024

This podcast was initially sparked by Josh’s “Note From a Family Meeting” Substack post titled “ Ambivalence in Clinical Decision-Making ,” which discussed Bryanna’s and Jenny’s 2022 article titled “ Two Minds, One Patient: Clearing up Confusion About Ambivalence.” What about ambivalence on the part of the provider?

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The Clinical Problem Solvers

MAY 2, 2023

[link] CPSolvers: Antiracism in Medicine Series Episode 21 – Psychosocial and Cultural Considerations for Providing Healthcare to Immigrant and Refugee Populations Show Notes by Kiersten T. This discussion is hosted by Sudarshan Krishnamurthy, Ashley Cooper, and LaShyra Nolen.

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GeriPal

APRIL 17, 2025

Farah provides clear examples from the Biden administration, in which having the most diverse cabinet in history was critical to building bridges, empathy, and inspiring others to feel included. Alex 20:58 Farah, appreciate the medicine metaphor for our clinical audience. And the uprooting of DEI is an act of violence. Well played.

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