FDA Law Blog

SEPTEMBER 10, 2023

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. In all cases, applicable requirements regarding informed consent (21 CFR Part 50) and Institutional Review Board review (21 CFR Part 56) must be met.

Provider 108

Provider Patient-Centered Clinic Patients 108

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

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. So there’s an event or a series of events. So there’s an event or a series of events. Kate 04:53 As well as how they cope with that event.

IT 67

IT Patient-Centered Individual Patients 67

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. Psilocybin, the most commonly used psychedelic, increases heart rate and blood pressure, which may potentially lead to cardiovascular events. Most participants are White and well-resourced.

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

MAY 25, 2023

Knowledge push the we’re actually testing the Conversation Project toolkit in our second arm, and that toolkit is great because it does provide knowledge and background and stories. We provide a $300 stipend for like food and marketing or whatever we provide all the materials needed for the event. LJ: Totally.

Community 96

Community IT Patient-Centered Primary Care 96

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

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. How should I define cachexia and anorexia when I’m talking to fellow students or thinking about it in my own clinical practice? I think the very simple, practical thing is involuntary weight loss.

Illness 133

Illness Patient-Centered Patients IT 133

Physician's Weekly

JUNE 11, 2025

“People with human immuno deficiency virus (HIV; PWH) face an approximately 2-fold increased risk of atherosclerotic cardiovascular disease (ASCVD) compared with individuals without HIV,” researchers wrote in Clinical Infectious Diseases. Modeling for hard MACE, MI, and stroke provided generally similar results for most variables.

Hypertension 52

Hypertension Individual Clinical Practice Diagnosis 52

BMJ

JUNE 25, 2021

1 Clinical guidelines internationally recommend statin therapy for both primary and secondary prevention of CVD, making statins one of the most frequently prescribed drugs in industrialised countries. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time. 16 Figure 1.

Primary Care 40

Primary Care Clinical Practice Electronics Clinic 40

GeriPal

JULY 13, 2023

He really practiced what he preached. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. And if I remember that study correctly, it was priming both patients and providers in the outpatient setting to do goals of care conversations.

Patient-Centered 84

Patient-Centered IT Patients Hospital 84