GeriPal

MAY 5, 2022

And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. It’s because they literally couldn’t access the information. Hearing aids, you had six big manufacturers of hearing aids. Five big manufacturers. Is that right? It changes the words.

IT 102

IT Screening Hospital Clinic 102

FDA Law

JUNE 4, 2025

The Assessment suggests that FDA may be viewing indication claims with greater scrutiny moving forward, either at the time of approval or after, when such information may be available. Known clinically relevant safety and effectiveness information is generally included in the label under current practices.

Chronic Disease 59

Chronic Disease Government Clinic Chronic Condition 59

FDA Law

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. Information related to the importation (e.g., See 21 C.F.R. 251.5; § 251.6(c).

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59

FDA Law

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