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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Maine Academy of Family Physicians

JULY 11, 2024

Doc4aDay is a community outreach program provided through the Maine Medical Center Department of Medical Education. For the past few years, MAFP has provided financial support for this opportunity hoping to encourage young adults in communities under-represented in medicine to become physicians (and hopefully family physicians!).

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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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My Green Doctor

APRIL 4, 2025

In This Issue : New Research: Teaching Patients about Climate Resilience Make the Pledge Today to Go Green Get Ready for Earth Day 2025 (part 2)! It tells your office colleagues and patients that your healthcare practice or clinic is committed to forging a healthier work space and community. The healthcare sector contributes 8.5%

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FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J.

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BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2020-000845 The appetite for and ability to collect accurate digital patient-level data in low-resource settings has fueled numerous massive global health initiatives. As impressive as these large numbers may be, the question that is less often asked is “How much of that big data is actually helping us do better?”

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LEAD Physician

SEPTEMBER 26, 2022

Physicians must be leaders in their field to provide excellent patient care, manage a large team and coordinate between departments, and support their patient's overall health with information about prevention and maintenance. For example, a physician might be dealing with a patient who has just been diagnosed with cancer.

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FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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GeriPal

JUNE 26, 2025

And then when you see clinically patients coming into hospital, they’ll have, you know, they’ll be admitted for aspiration pneumonia. There are probably other pneumonias that don’t are treated as patients or patients are in hospice at the time that they develop the pneumonia and they’re not hospitalized.

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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.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., use in education, construction, art, and jewelry).

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ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Dr. McDonald explained that the LKA provides MOC points for questions answered correctly, but since ABIM is not an accreditation organization, it does not offer CME credit.

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FDA Law Blog

OCTOBER 12, 2022

Most states have some form of naloxone standing order that allows a healthcare provider to write a prescription that covers a large group of people rather than just an individual patient. syringes), to any individual without a patient-specific prescription. plies for administration (e.g.,

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CDOCS

MARCH 4, 2024

Providing opportunities to learn new skills and advance their careers not only enhances job satisfaction but also improves the patient experience.<br Every minute of the day is important, but this time will pay off for you, your team and your patients in the long run. </p>

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CDOCS

JUNE 3, 2021

<p><span style="font-size:14px;">The Spear Facially Generated Treatment Planning workshop I took early in my career had a massive impact on the amount of comprehensive dentistry I can now see and diagnose and present to my patients. I present to you Greg.</span></p>

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FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

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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. The report recommends using a QMM rating that is shared throughout the market (purchasers, consumers, competing manufacturers) to provide manufacturers committed to QMM with a competitive advantage.

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Management Manufacturing Supply Chain Provider 45

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.” Specifically, that it allows for fast production of “patient-matched devices” (i.e., use in education, construction, art, and jewelry).

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FDA Law Blog

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.

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Manufacturing Engineering Clinic Provider 59

GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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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. This could occur during an End-of-Phase 2 (EOP2) meeting if a Phase 2 study is expected to provide primary evidence of safety and effectiveness.

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GeriPal

JANUARY 12, 2023

Which patients are eligible to go to an ACE unit? So I picked the Ed Sheeran song, The A Team, because it reminds me of our ACE team that goes around the hospital and cares for our older patients. And a light bulb just went off in my head, like, yes, this makes sense as a model for how we should care for more complex older patients.

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Hospital Patient-Centered IT Nurse Practitioner 101

CDOCS

MARCH 28, 2025

These small composite additions provide essential grip and force application, allowing aligners to move teeth with precision. </span><span <br /> <br /> <a href="[link] Aligner Excellence for Dentists and Their Teams (Part 1) workshop. </a><br

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Patient-Centered Provider Patients IT 52

GeriPal

DECEMBER 2, 2022

She directs UCSF MERI’s patient, family, and clinician support with classes and consultation on resiliency, well-being, and grief. You wrote about how when it comes to talking about patients with dementia, they’re rarely portrayed as resilient. And the person with dementia, the patient, said yes. I want to hug you.

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Community IT Individual Patient-Centered 102

FDA Law Blog

MARCH 13, 2023

Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J. Bauer, Senior Regulatory Drug Expert & James E.

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FDA Law Blog

FEBRUARY 11, 2025

Houck One of the most significant issues facing hospitals and other facilities is the diversion of controlled substances meant for patients by physicians, pharmacists, nurses and other trusted healthcare employees. By Larry K. Click here to learn more about the Opioid & Abuse Management Congress.

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Management Hospital Healthcare Patients 59

Maine Academy of Family Physicians

OCTOBER 22, 2023

I observed multiple fascinating procedures and patient interactions throughout the externship, and I am grateful to have had the opportunity to glimpse the day-to-day of this field. At the Family Medicine office, I observed the close relationships fostered between Dr. Der Simonian and her patients.

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Medical Student Family Medicine DO Patient-Centered 40

GeriPal

OCTOBER 12, 2023

Summary Transcript Summary For surgeons and patients, deciding if and when to operate can be challenging. Often, the way surgeons communicate about these decisions doesn’t make things any easier for themselves or their patients. We hope you enjoy this episode. I did it before and this guy, he was 85, but he was climbing Mount Everest.”

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FDA Law Blog

MAY 3, 2022

During the episode, Oliver provides examples of medical devices featured as part of spon-con on local news stations, and demonstrates how his team was able to buy local news time to promote “ the world’s first sexual health blanket.”). Katie discusses using Duobrii when she has a flare up and seeing results within days.

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GeriPal

OCTOBER 3, 2024

Alex 00:08 UCSF’s Division of Palliative Medicine are looking to build on their research and clinical programs and are interviewing candidates for the associate chief of research position and for full time physician faculty to join them in the in-patient and out-patient settings. I wonder why you did that.

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GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. Jennifer 04:25 I can take that on. Eric 05:32 Yeah.

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Patient-Centered IT Patients Hospital 120

GeriPal

MARCH 16, 2023

So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. Rosanne: I think I was motivated by the number of times patients asked me to get rid of their pot-bellies, quite honestly. Rosanne: I certainly do. Eric: Yeah.

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GeriPal

AUGUST 15, 2024

Ongoing reports from patients about anti-Asian hate experiences Should clinicians screen for Anti-Asian hate? This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism.

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GeriPal

APRIL 21, 2022

Poetry puts us in our patient’s shoes. Poetry holds us in that liminal space so many of our patients are in. To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. Links to Redwing’s poetry workshops: Food for Thought Poetry for Resiliency.

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Patient-Centered IT Community Illness 93

GeriPal

NOVEMBER 3, 2022

You’d imagine though that our professional expertise and experiences in helping patients and families cope with loss and grief would be helpful in managing our own personal losses. Eric: We’re going to be talking about loss and grief and the role of debriefing for healthcare providers. Turns out, it’s maybe not. Eric: Yeah.

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Healthcare Professional Healthcare IT Relationship 103

FDA Law Blog

APRIL 20, 2025

This rings particularly true amongst the rare disease patient community, along with many small biotech companies (and their investors) that take on the risk of developing orphan drugs for exceedingly small patient populations. Patients and their families and caregivers have long fought to have a seat at the table with decision-makers.

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