FDA Law Blog

NOVEMBER 1, 2022

Brevig, Senior Regulatory Device and Biologics Expert — On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” Opportunity for feedback from FDA if provided pre-BLA.

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Manufacturing Clinic Provider IT 59

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.

Clinic 40

Clinic Individual Provider Healthcare 40

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!

Healthcare Professional 52

Healthcare Professional Healthcare Community Medical Advice 52

BMJ

AUGUST 20, 2021

In its best use case, such technology would provide the foundation of person-level digital information systems that can be used to accurately collect and use data in at two critical levels: in real-time to improve individual patient outcomes, and aggregated to monitor the health status of a population, i.e. the big numbers.

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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.

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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Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices.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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Patients Patient-Centered Clinic Medical 59

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. Leadership skills are crucial for physicians, who represent one of the most important occupations in our society.

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Relationship Education Management Patients 52

FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

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Patients Clinic Medical Patient-Centered 52

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. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

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Patient-Centered Manufacturing Clinic Provider 52

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.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. This guidance document is still in effect today.

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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. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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Manufacturing Engineering Clinic Provider 59

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.

Clinic 59

Clinic Provider IT Electronics 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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IT Patient-Centered Patients Clinic 120

ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

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Board-Certified Board-Certified Physicians Community Government 40

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 Now is the time to change that! Dental assistants trained in specialized procedures can enable the practice to expand its service offerings. </p>

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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. For example, the Maryland standing order allows all Maryland licensed pharmacists to dispense naloxone, including any necessary sup??

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Supply Chain Individual Provider Patient-Centered 52

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. FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for Drug Development website.

Patient-Centered 52

Patient-Centered Clinic Medical Utilities 52

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.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. This guidance document is still in effect today.

Medical 75

Medical Manufacturing Healthcare Government 75

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.

Management 45

Management Manufacturing Supply Chain Provider 45

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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Hospital Patient-Centered IT Nurse Practitioner 100

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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Community IT Individual Patient-Centered 101

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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Patients Patient-Centered Families Family 98

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.

Clinic 59

Clinic Telehealth IT Provider 59

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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IT Families Family Patient-Centered 128

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.

Medical Student 40

Medical Student Family Medicine DO Patient-Centered 40

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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IT Patient-Centered Patients Relationship 122

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. How do you find time to write and also be doctors and academic professors? In all seriousness, you don’t actually have to want to write a book to be interested in this podcast.

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IT Healthcare Professional Healthcare Transportation 105

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.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

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.

Illness 73

Illness Hospital IT Patient-Centered 73

GeriPal

NOVEMBER 3, 2022

So take a listen and check out some of these resources for healthcare provider loss, grief, and wellness: Loss and Grief: Personal Stories of Doctors and Other Healthcare Professionals. Eric: We’re going to be talking about loss and grief and the role of debriefing for healthcare providers. Craig: Thanks so much, Alex and Eric.

Healthcare Professional 102

Healthcare Professional Healthcare IT Relationship 102

GeriPal

APRIL 21, 2022

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. The impossiblity which is life, which is everything, and death, which is the end of life. To let it go. . AlexSmithMD

Patient-Centered 93

Patient-Centered IT Community Illness 93

GeriPal

AUGUST 15, 2024

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. Proposing the clinicians ask a simple follow up question to the usual “do you feel safe at home?” So here is a little bit.

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Mental Health Community Screening IT 116

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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Patients Patient-Centered Community Individual 89