GeriPal

MAY 5, 2022

And that’s true across the spectrum of care, but it becomes increasingly important when you think about people with multiple chronic conditions, who really do have to make some of these very difficult conversations and decisions. Hearing aids, you had six big manufacturers of hearing aids. Five big manufacturers.

IT 102

IT Screening Hospital Clinic 102

FDA Law Blog

JUNE 4, 2025

However, as the Assessment notes, [t]here aremany possible adverse events for which there is inadequate evidence to accept or reject a causal relationship, which may otherwise lead manufacturers to opt not to include them in the labeling.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

FDA Law Blog

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. See 21 C.F.R. 251.5; § 251.6(c). Customs and Border Protection (CBP) port of entry.

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate. Part D currently has no such cap.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98