Physician's Weekly

JUNE 13, 2025

There is robust data regarding the importance of patient connection and engagement in the hospital and clinic setting. Many of us are taught in medical school and residency the importance of patient communication on improving patient satisfaction scores, quality metrics, and professional fulfillment.

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FDA Law Blog

JUNE 21, 2021

Sasinowski — On June 17, 2021, FDA gave notice of an upcoming public workshop focused on clinical trial designs for progressive multifocal leukoencephalopathy (PML). The virtual workshop will take place on September 21, 2021, and a public docket seeking comments on the workshop will remain open until November 1, 2021.

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CDOCS

MARCH 25, 2021

</span></p> <p style="font-family:ubuntu"><span style="font-size:14px;">The solution came in the form of attending a CDOCS workshop and the Dentsply Sirona Clinical Accelerator Program.</span></p> Something was off. To put it bluntly, she was bored.</span></p>

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My Green Doctor

APRIL 4, 2025

It tells your office colleagues and patients that your healthcare practice or clinic is committed to forging a healthier work space and community. Encourage Small Changes That Add Up Shift your clinic toward paperless records and LED lighting to reduce waste and energy costs. Let’s talk! Need help planning an event?

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FDA Law Blog

JULY 17, 2024

These are exactly the types of things that were addressed at ELF Scientific Workshop in May 2024 which addressed challenges in developing therapies for ultra rare diseases (see our blog about this here , which includes a link to the recording).

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FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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BMJ

AUGUST 20, 2021

Low-resource settings provide unique challenges to adoption: frequently there are a low number of care providers serving a higher number of patients, supervision is conducted less regularly due to travel times, and current clinical guidelines might not be readily available.

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LEAD Physician

SEPTEMBER 26, 2022

For example, one can have a vision of having an on-site medical clinic where patients can receive care without traveling long distances for treatments or procedures. Aspiring medical leaders should look for opportunities to enhance their leadership skills through CME courses, seminars, workshops, and conferences.

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FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

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FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. The Agency will hold as many as three public workshops during PDUFA VII related to rare disease endpoint development.

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GeriPal

JUNE 20, 2024

George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. On our last podcast about urinary incontinence the song request was, “Let it go.” This time around several suggestions were raised. Eric suggested, “Even Flow,” by Pearl Jam. I suggested even flow. That’s a good one.

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” In this scenario, FDA is interested in the possibility of frequent design changes that may occur in response to clinical feedback (e.g.,

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FDA Law Blog

JANUARY 4, 2023

The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023. The Agency stated that the most common reason for a clinical hold of a Phase 1 study under an investigational new drug (IND) is related to safety. The workshop is also discussed in Cell & Gene here and here.

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CDOCS

MARCH 4, 2024

Whether it's through assisting in advanced treatments like dental implants or expanding their clinical functions, a broader range of services can attract more patients and increase revenue streams. Now is the time to change that! Dental assistants trained in specialized procedures can enable the practice to expand its service offerings.

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FDA Law Blog

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. In March of this year, FDA convened the first public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review.

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FDA Law Blog

DECEMBER 6, 2024

CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc. The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

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Aspiring Minority Doctor

JUNE 1, 2022

My intent this year was to at least update everyone at the end of every month, but work and life distracted me from my favorite hobby of writing. I'll try my best to catch everyone up with this post, and for the sake of time, I'll try to keep it relatively brief since I know I can get a bit wordy. I love my Plastic Surgery residency family!

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FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” In this scenario, FDA is interested in the possibility of frequent design changes that may occur in response to clinical feedback (e.g.,

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FDA Law Blog

OCTOBER 12, 2022

Harm reduction programs typically aren’t medical clinics or pharmacies and would not hold any state licenses that would allow them to purchase prescription drugs; although, at least one state (Rhode Island ) has created a licensure category for harm reduction centers. While certain states do define “harm reduction programs” (e.g.,

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ABIM

APRIL 24, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research. The following is a summary report of the spring meeting.

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GeriPal

DECEMBER 2, 2022

Summary Transcript Summary. What would it take to transform dementia care? Alex: We have a full house today. We’re delighted to welcome Judy Long, who’s a palliative care chaplain at UCSF and a caregiver. Judy, welcome to the GeriPal podcast. Judy: Thank you. It’s great to be here. Alex: Great. So take it away. When was that, 2010?

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GeriPal

JANUARY 12, 2023

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? . What does the future look like for ACE units and how does it differ (if at all) from Age Friendly Health Systems? But before we do, do you have a song request? I think Kellie, do you have it? Alex: Yeah.

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FDA Law Blog

MARCH 1, 2023

The lessons learned were also discussed during a November 2022 workshop hosted by the FDA. On November 2, 2022, the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee held a meeting on CDER’s QMM Program. FDA describes the QMM as “above-the-bar behaviors” that exceed good manufacturing practices (GMPs).

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FDA Law Blog

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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GeriPal

OCTOBER 12, 2023

Gretchen: Yeah, I think probably the underlying story here is that I’m really good at doing negative randomized clinical trials, but there is a good thing about doing a big clinical trial, which is that you get tons of data even if you don’t end up with the result that you want. Justin, welcome to GeriPal. Justin: Hello.

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Maine Academy of Family Physicians

OCTOBER 22, 2023

I also spent one day at the Maine Family Planning clinic in Augusta, shadowing the head clinician, Lindsey Piper, NP. I feel very fortunate to have had the opportunity to shadow the head nurse practitioner at the Augusta clinic. As a full spectrum physician, Dr. Der Simonian cares for patients throughout all stages and walks of life.

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GeriPal

OCTOBER 3, 2024

How the act of drawing can help us sloooow down, pay attention to the people and world around us, and ultimately let go… The possibility of incorporating drawings in research and even clinical care. Some highlights from our conversation: The role of art in humanizing the dying process. Sit down and draw each other for only one minute.

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GeriPal

MARCH 16, 2023

How do you find time to write and also be doctors and academic professors? Revisions and working with editors Writing an Op Ed – how to start, what to write, where to send it TheOpEdProject as a resource for learning more We look forward to the books and op-eds our listeners will write! Welcome to the GeriPal podcast, Rosanne.

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GeriPal

SEPTEMBER 19, 2024

Summary Transcript CME Summary If palliative care was a drug, one question we would want to know before prescribing it is what dose we should give. Give too little – it may not work. But before we jump into that topic, Jennifer, do you have a song request for Alex? Jennifer 01:20 I do have a song request for Alex. Saw them play a couple times.

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GeriPal

JUNE 26, 2025

But from our clinical work, many of us are familiar with people with dementia who experience sudden shocks to their health, think hip fracture, think hospitalization for pneumonia. Summary Transcript CME Summary June Lunney famously characterized the end of life functional course of people with dementia as a slow dwindle over time.

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GeriPal

APRIL 21, 2022

Links to Redwing’s poetry workshops: Food for Thought Poetry for Resiliency. The impossiblity which is life, which is everything, and death, which is the end of life. As Mary Oliver tells us In Blackwater Woods , and I’m paraphrasing here, we must to hold it to our bones, knowing our lives depend on it, and when the time comes, to let it go.

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GeriPal

NOVEMBER 3, 2022

Eric: And why’d you pick that song? Vickie: It just reminds me of how important collegial support and being with each other is. Alex: Great choice. Eric: Thank you, Alex.All right, let’s jump into the topic at hand, loss and grief. I want to start off by turning to Matt. Matt, tell me about the book that you just published.

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GeriPal

AUGUST 15, 2024

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. Jessica, welcome back to GeriPal. So here is a little bit.

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FDA Law Blog

APRIL 20, 2025

We want to give FDA review officials the tools they need to be able to reduce barriers and customize what development looks like for ultra rare products (see, e.g., coverage of Frank Sasinowskis remarks at the May 21, 2024 EveryLife Foundation for Rare Diseases Scientific Workshop, Debating a new pathway for ultrarare ). Its incurable.

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