FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Ikaria Software Upgrade for Inomax Drug Delivery System

[ Price : $8.95]

FDA clears an Ikaria 510(k) for a software upgrade to enable connectivity of the Inomax DSIR drug delivery system with hospital he...

Group Wants Harmonized API Regs

[ Price : $8.95]

The European Fine Chemicals Group calls for global harmonization of active pharmaceutical ingredient rules and regulations.

FDA OKs Medtronics Valiant Captivia Stent for Aortic Injuries

[ Price : $8.95]

FDA approves Medtronics Valiant Captivia stent graft system for repairing blunt traumatic aortic injuries.

QS Violations Found in Westone Labs Inspection

[ Price : $8.95]

FDAs Denver District Office warns Westone Laboratories about QS violations in its manufacturing of the Oto-Ease patient lubricant....

FDA Accepts Geno NDA for Nitric Oxide System

[ Price : $8.95]

FDA accepts for review a GeNO LLC NDA for GeNOsyl MVG-2000 Nitric Oxide Delivery System for neonates with hypoxic respiratory fail...

Some Whistleblower Records Properly Withheld: Court

[ Price : $8.95]

A DC federal court rules that HHS acted properly in redacting and withholding some documents sought by CDRH whistleblowers.

Academic Groups Air Biosimilar Patent Concern

[ Price : $8.95]

Leaders of six higher education associations ask FDA for a requirement that biosimilar applicants certify their compliance with th...

Reviewers Say Dynavax Hep B Vaccine is Effective

[ Price : $8.95]

CBER clinical reviewers tell the Vaccines and Related Biological Products Advisory Committee that Dynavax Technologies Heplisav ap...

Latest FDA Warning Letters

[ Price : $8.95]

In its latest batch of Warning Letters, FDA cites The Avalon Effect, Health Breakthroughs, I. Shay Cosmetics, Mushroon Wisdom, and...

Microgenics FDA-483 Posted for June Inspection

[ Price : $8.95]

A June FDA inspection of Microgenics Fremont, CA facility cites the firm for failing to adequately investigate complaints related ...