Roster of the Vaccines and Related Biological Products Adv Cmte

by Pill Pals Customer Service | Aug 28, 2025 | News

Applying for Membership on FDA Advisory CommitteesAs part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is...

Table of Surrogate Endpoints

by Pill Pals Customer Service | Aug 28, 2025 | News

Acquired HypofibrinogenemiaBleeding adults with acquired fibrinogenemiaThe total number of allogeneic blood product (ABP) units transfused in the first 24 hours after termination of cardiopulmonary bypass (CPB).TraditionalReplacement for fibrinogen, a critical soluble...

Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6

by Pill Pals Customer Service | Aug 28, 2025 | News

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.Affected ProductProduct Names: HAMILTON-C6...

FDA to recommend additional, earlier MRI monitoring for patients

by Pill Pals Customer Service | Aug 28, 2025 | News

During routine pharmacovigilance, FDA identified six fatal cases of amyloid related imaging abnormalities with edema (ARIA-E) early in treatment. These fatalities prompted an in-depth analysis of serious and fatal outcomes of ARIA-E occurring prior to the 5th infusion...

VRBPAC December 12, 2024 Meeting Announcement

by Pill Pals Customer Service | Aug 28, 2025 | News

On This Page Date: December 12, 2024 Time: 8:30 a.m. – 5:30 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on...

ICU Medical Inc. Issues Correction for Plum Duo Infusion System

by Pill Pals Customer Service | Aug 28, 2025 | News

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without...