FDA Law Blog

JUNE 10, 2024

In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. 11-12 of the guidance for a list of these resources). Ask clarifying questions.

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Provider Electronics Clinical Practice Management 111

FDA Law Blog

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice.

Medical 111

Medical Clinic Patients IT 111

The Clinical Problem Solvers

OCTOBER 18, 2022

Providing communities with the resources they need to survive, such as educational opportunities, jobs, and quality healthcare, will eliminate the need for incarceration. We need a system, such as a single-payer healthcare system, that provides people with consistent access to high-quality care before, during, and after incarceration.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 52

ABIM

APRIL 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. 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.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

The Clinical Problem Solvers

DECEMBER 16, 2020

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

Clinic 52

Clinic Medical Provider Patients 52

PEMBlog

AUGUST 30, 2023

ED providers and radiologists commonly face the scenario of interpreting a CXR in a child with respiratory complaints prompting the questions: Does that infiltrate represent bacterial pneumonia, inflammation, or simply atelectasis? Drivers of CXR overuse are myriad and can be thought of at the system, provider, and patient levels.

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

GeriPal

JANUARY 23, 2025

Join us as we dive deeper into these studies and discuss the implications for clinical practice and patient care. Alex 14:45 And is it ethical to do a placebo taper in real world clinical practice? Ethical and practical. Eric 15:32 Could do this in clinical practice. You make the clinical decisions.

Specialization 119

Specialization IT Patient-Centered Medical 119

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective.

Screening 119

Screening Primary Care Patient-Centered IT 119

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.

IT 120

IT Patient-Centered Patients Clinic 120

GeriPal

JANUARY 12, 2023

” And the environment that we worked in, in geriatrics, was more of this sharing information and different groups or calling. I spent so much time trying to talk to others to find out this information. But we do have information on how many of those exist and a few details about how they run as well.

Hospital 100

Hospital Patient-Centered IT Nurse Practitioner 100

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. So this is a podcast going at the geriatricians and palliative care providers. I’m guessing not. Eric: Great.

IT 102

IT Screening Hospital Clinic 102

GeriPal

JUNE 12, 2025

Eric 00:42 So on this podcast, we’re gonna be talking about what every healthcare provider should know about radiation oncology. I didn’t really know, similar to what Evie was talking about, how to provide any anticipatory guidance or to know what to expect in residency. Evie, welcome to GeriPal. Evie 00:41 Thank you.

Patient-Centered 102

Patient-Centered Referral Patients IT 102

FDA Law Blog

SEPTEMBER 10, 2023

In all cases, applicable requirements regarding informed consent (21 CFR Part 50) and Institutional Review Board review (21 CFR Part 56) must be met. Even though an IND is not required, this guidance is intended to provide recommendations for sponsors to follow for using RWE from such studies for regulatory decision-making.

Provider 108

Provider Patient-Centered Clinic Patients 108

GeriPal

FEBRUARY 20, 2025

Summary Transcript CME Summary Trauma is a universal experience, and our approach as health care providers to trauma should be universal as well. With that said, there is so much more that I learned from our guests for this trauma-informed care podcast. Eric 00:15 And we have three guests to help us talk about trauma informed care.

IT 67

IT Patient-Centered Individual Patients 67

ABIM

JUNE 4, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. They also noted a distinction in telehealth practices between remote consultations in different states and using telehealth to treat patients who live nearby.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information. Advanced Practice Providers in the Hematology-Oncology Workforce* Guinevere Z. ASH has engaged in lobbying efforts in Washington, D.C.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

FDA Law Blog

MARCH 17, 2022

Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. et al, CDC Clinical Practice Guideline for Prescribing Opioids-United States, 2022, CDC. Proposed 2022 CDC Practice Guideline, 7,839. CDC Clinical Practice Guideline, 10. 7,838 (Feb. 10, 2022); Dowell, Deborah, MD.,

Patient-Centered 75

Patient-Centered Clinical Practice Patients Individual 75

ABIM

JUNE 11, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. Several members of the Infectious Disease Board noted that allowing applicants to select multiple categories and provide written details helps reflect the diversity of practice in the field.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

MAY 30, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier to find information for both physicians and the public. Dr. Adey has provided updates to the Nephrology Board about this process at the last two meetings ( fall 2024 and spring 2024 ). Rodriguez, MD , Chair of the Nephrology Board, and John C.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

FDA Law Blog

MARCH 6, 2025

In the context of a PCCP, the DCP should also address when new data should be acquired and/or older data removed to ensure the datasets remain current with respect to acquisition technologies, clinical practices, changes in the patient population, and disease management. The DCP should address if there are missing data elements (e.g.,

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. Guideline opioid use recommendations “are not intended to be used as an inflexible, rigid standard of care; rather, they are intended to be guideposts to help inform clinician-patient decision-making.” MMWR Recomm Rep 2022;71(No. RR-3):1–95.

Patients 52

Patients Patient-Centered ER Individual 52

GeriPal

JANUARY 18, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. But the cancer specific databases just don’t have this information. It’s opening this stock box of, all of a sudden, now what do I do with this information?

Illness 136

Illness Patient-Centered Screening IT 136

GeriPal

APRIL 4, 2024

The Cruzan ruling led to a flood of interest in Advance Directives, and eventually to the Patient Self Determination Act, which mandates provision of information about advanced directives to all hospitalized patients. Other states set lower bars, including oral assignment of surrogate decision-makers. AMA PRA Category 1 credit(s) ™.

Family 112

Family Families Patient-Centered IT 112

GeriPal

FEBRUARY 29, 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. Alex: Yeah.

IT 126

IT Patient-Centered Illness Education 126

GeriPal

JUNE 27, 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.

Illness 129

Illness IT Diagnosis Patient-Centered 129

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. We’re going to work with training up the providers that already work in these clinical settings to make it a little bit more, essentially, ask this question of how is this going to work in the real world?

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

SEPTEMBER 12, 2024

I must admit, though, sometimes it just feels off… inauthentic, as if it’s not a genuine desire to improve our lives as health care providers, but rather a metric to check off or a desire to improve productivity and billing by making the plight of workers a little less miserable. Like, we are not ever included to do that.

IT 111

IT Healthcare Healthcare Professional Patient-Centered 111

GeriPal

FEBRUARY 27, 2025

Substance use disorder is one of those complex issues in which clinical practice is changing rapidly. But, you know, I’ve talked to a lot of palliative care providers, a lot of people caring for people with serious illness. You can listen to our prior podcasts on substance use disorder here , here , here , and here.

Patients 73

Patients Clinic Patient-Centered Illness 73

GeriPal

MAY 25, 2023

Sarah: Yeah I similarly feel like, you know, focusing more on the process, the qualitative kind of from a research standpoint, the qualitative information that we’re getting from folks. We don’t push any information at them. LJ: We provide all the marketing materials. Hillary or Sarah. Thoughts on that.

Community 96

Community IT Patient-Centered Primary Care 96

GeriPal

FEBRUARY 9, 2023

Alex: We are delighted to welcome Amber Barnato, who’s a palliative care physician and health service researcher, and she’s director of the Dartmouth Institute for Health Policy and Clinical Practice. What should our listeners take away from this study in clinical practice? Amber: Thank you guys.

Patient-Centered 111

Patient-Centered Patients IT Healthcare 111

GeriPal

AUGUST 24, 2023

And the role of the palliative care provider is to figure out, knowing that different things affect different people, is what causes somebody in that particular instance to feel their dignity is being undermined. And the data was saying, “What is really important is the way you, the care provider, experience that person.”

Patient-Centered 98

Patient-Centered Patients IT Illness 98

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. It’s just that he was foregoing things that we think would have provided him more benefit. An increasing number of federal leaders have a track record of endorsing such products.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

GeriPal

MARCH 28, 2024

Kate: The problem is we communicate late, we share prognosis late, we elicit goals and values late, so all the time while they’re in the ICU getting prolonged intensive care, we don’t really know that we’re providing goal concordant care, so we wanted to nudge it a little upstream. Eric: Nudge it. Kate: Nudge it.

Consulting 115

Consulting Patient-Centered IT Patients 115

GeriPal

MARCH 10, 2022

The Lived Experience of Providing Feeding Assistance to a Family Member with Dementia. Well, I’m a geriatric nurse practitioner and I provided care to over 800 nursing home residents in 11 different nursing homes. I was really struck by the difference in care provided to people with advanced dementia. Rehabbed to Death.

Nurse Practitioner 60

Nurse Practitioner Hospital Family Families 60

GeriPal

OCTOBER 19, 2023

It’s like how liberating it is to eliminate resentments, regrets and envy from our lives and how great it is in our clinical practice when we’re able to help families reconcile after an estrangement, how much relief that brings. So I do think it’s useful to have that additional information.

Patient-Centered 126

Patient-Centered IT Patients Illness 126

GeriPal

JUNE 13, 2024

I feel like I recognize it when I see it, but I struggle to give a clear definition or provide effective ways to address it. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. AMA PRA Category 1 credit(s) ™.

Illness 133

Illness Patient-Centered Patients IT 133