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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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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Patients Clinic Medical Patient-Centered 52

ABIM

APRIL 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Dave noted the Diplomate Professional Profile’s potential outside of Specialty Board discussions with data that could be valuable to patients with specific needs and conditions.

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FDA Law Blog

AUGUST 23, 2023

By the end of Q2 FY 2023, FDA will convene the first of a series of 5 public meetings or workshops with key stakeholders including patients, biopharmaceutical companies, DHT companies, and academia to gather input into issues related to the use of DHTs in regulatory decision-making.

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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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Supply Chain Individual Provider Patient-Centered 52

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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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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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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FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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CDOCS

MARCH 28, 2025

important; line-height:20.85px; margin:0px; padding:0px; user-select:text; white-space-collapse:preserve" xml:lang="EN-US">A vertical rectangular attachment placed at the center of the crown serves as a force distributor, helping the aligner exert consistent pressure across the tooth.

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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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Maine Academy of Family Physicians

OCTOBER 22, 2023

Der Simonian at the Falmouth Family Medicine office and at the Maine Medical Center Mother Baby Unit. 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.

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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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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. My friend Joan Halifax and I often teach together.

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IT Patient-Centered Patients Relationship 122

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 119

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. Links to Redwing’s poetry workshops: Food for Thought Poetry for Resiliency. Alex: We also have Mike Rabow, who is director of palliative care at the Cancer Center at UCSF. AlexSmithMD . Advance Care Planning.

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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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Mental Health Community IT Screening 116

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. Health care professionals are human, and as humans we experience loss both in and out of work. Turns out, it’s maybe not. Craig: Thanks so much, Alex and Eric.

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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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