FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Early Alert on Abiomed Heart Pump Controller Software Problem

[ Price : $8.95]

FDA issues an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by ...

Guidance Raises Expectations for Form 483 Responses, Expert Says

[ Price : $8.95]

A regulatory expers says FDAs recent draft guidance on Form-483 responses is signaling tougher expectations for how drug manufactu...

Clarity Sought on FDA New Approach Methodologies Guide

[ Price : $8.95]

Stakeholders suggest ways FDA could clarify a draft guidance on using new approach methodologies in drug development.

React Health Recalls Ventilators Due to Manufacturing Issue

[ Price : $8.95]

React Health recalls certain VOCSN V+Pro ventilators due to a manufacturing issue that could lead to undetected oxygen leaks and p...

Bolton Thoracic Stent Recall is Class 1: FDA

[ Price : $8.95]

FDA says a Bolton Medical recall of its RelayPro thoracic stent graft system is Class 1.

Clinical Electronic Structured Protocol Template

[ Price : $8.95]

FDA publishes for reference only an International Council for Harmonization template on a clinical electronic structured harmonize...

Comments on Increasing Access to Non-Prescription Drugs

[ Price : $8.95]

Four stakeholders comment to FDA on ways to increase patient access to nonprescription drugs.

FDA to Convene Panel on Modernas mRNA Flu Vaccine

[ Price : $8.95]

FDA announces a 6/18 advisory committee meeting to review Modernas controversial mRNA-based seasonal influenza vaccine.

RFK Jr. Ignores Hill Request on Anti-Vax Activist HHS Role

[ Price : $8.95]

HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime ...

Lilly Says Retatrutide Delivered Up to 30% Weight Loss

[ Price : $8.95]

Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results approaching those historically as...