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ICH M14 Pharmacoepidemiological Studies Guide

[ Price : $8.95]

FDA publishes a draft International Conference on Harmonization M14 guidance on planning, designing, and analyzing observational p...

Device Total Product Life Cycle Advisory Program Continues

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CDRH extends its Total Product Life Cycle Advisory Program to include devices reviewed in the Office of Radiological Health, the D...

Guidance on Addressing Regulated Product Misinformation

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FDA publishes a draft question-and-answer guidance to help firms address misinformation about their approved or cleared medical pr...

Guide on Combo Product Risk Analyses

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FDA posts a draft guidance entitled Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combinati...

FDA WEBVIEW CLOSED JULY 4TH WEEK

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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...

Brookfield Medical/Surgical FDA-483

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FDA releases the form FDA-483 with four observations from an inspection at the Brookfield, CT-based Brookfield Medical/Surgical Su...

Drug Delivery Device Guidance

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FDA publishes a draft guidance recommending medical device design outputs essential for establishing and assessing drug delivery p...

Philips Updates BiPAP Ventilator Use Instructions

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FDA says Philips Respironics has updated use instructions for three BiPAP ventilators in a Class 1 recall.

SCOTUS Chevron Decision Harms the Public: Coalition

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The Coalition for Sensible Safeguards calls on Congress to enact Chevron deference into law following a Supreme Court decision gut...

Abbott Recalls HeartMate System Monitor

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Abbott Medical recalls (Class 1) its HeartMate System Monitor due to atypical behavior of the System Monitor screen.