FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Equipment Contamination Seen in 2 Aurobindo Inspections

[ Price : $8.95]

Indias The News Minute says FDA inspections at two Aurobindo drug manufacturing facilities raised concerns about equipment contami...

Conformis Hip System Cleared

[ Price : $8.95]

FDA clears a Conformis 510(k) for its Conformis Hip System.

FDA Needs AI Standards: Executive

[ Price : $8.95]

Charles Fisher, who founded an artificial intelligence company that works in drug clinical trials, urges FDA to develop a framewor...

FDA in 2 Collaborative Communities

[ Price : $8.95]

CDRHer Michelle Tarver says FDA is participating in two collaborative communities and wants to be in 10 by the end of 2020.

FDA Clears Dx 360 Rotatable Disposable Sheath

[ Price : $8.95]

FDA clears a UVision360 510(k) for the 3mm Luminelle Dx 360 Rotatable Disposable Sheath, an attachment for the Luminelle DTx Hyste...

Put Tramadol in High CSA Classification: Public Citizen

[ Price : $8.95]

Public Citizen petitions FDA and the Drug Enforcement Administration to up-classify Tramadol and similar drugs from Schedule 4 to ...

CBER Regulatory Meeting SOPP

[ Price : $8.95]

CBER issues a SOPP on regulatory meetings under some user fee programs.

GSK Asks FDA Review of Zofran Information

[ Price : $8.95]

GlaxoSmithKline asks FDA to look at four categories of information that have been raised in litigation over Zofran pregnancy label...

Vyaire Medical Gains Ventilator Clearance

[ Price : $8.95]

FDA clears a Vyaire Medical 510(k) for the bellavista 1000e ventilator.

Cell/Tissue Product eSubmission Instructions

[ Price : $8.95]

CBER posts Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).