FDA Law Blog

JANUARY 12, 2025

Whether a surrogate or intermediate clinical endpoint (ICE), the endpoint to support accelerated approval is one that can be assessed more rapidly than the ultimate clinical benefit; this is what enables earlier patient access than would be possible while generating the evidence to support a traditional approval, which is typically infeasible.

Clinic 64

Clinic Relationship Provider IT 64

GeriPal

OCTOBER 17, 2024

We talk about what is heart failure, particularly HFpEF, how we treat it (including the use of sodium–glucose cotransporter-2 inhibitors (SGLT2’s), and how we should apply guidelines to individual patients, especially those with multimorbidity who are taking a lot of other medications. When I see a patient? Matthew, I get the lyrics.

Primary Care 113

Primary Care Patient-Centered IT Patients 113

GeriPal

AUGUST 1, 2024

Widera and Smith have no relationships to disclose. Guests Anna Pleet, Elizabeth Eckstrom, and Emily Johnston have no relationships to disclose. So if you already have a condition, you might be able to prevent events. And I think that’s something that we can really focus on, especially with geriatric patients.

IT 116

IT Diabetes Patient-Centered Chronic Disease 116

GeriPal

JULY 6, 2023

All of them offer the same array of services, really emphasizing social determinants of health and preventive services like falls prevention, chronic disease, self-management, caregiver training. I would hope a referral would go to what’s called an ADRC, and it’s called an Aging and Disability Resource Center.

Community 89

Community Nurse Practitioner Provider IT 89