FDA Law

JANUARY 12, 2025

FDAs Overview of When Accelerated Approval is Appropriate The new draft guidance explains, that there are two circumstances in which the accelerated approval authority would most clearly apply: (1) when the course of the disease is long or (2) the clinical event that is relevant for demonstrating benefit occurs infrequently.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

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 knew them, I developed a relationship with them. It’s somebody different every month, and you never develop that relationship.

Community 89

Community Nurse Practitioner Provider IT 89