FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Abbott Recalls Amplatzer Delivery Sheath

[ Price : $8.95]

Abbott recalls its Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles to be introduced into patients und...

Defender Pharma NDA for Scopolamine Gel

[ Price : $8.95]

Defender Pharmaceuticals files an NDA for its intranasally administered scopolamine gel for preventing motion-caused nausea and vo...

Alert Update on Vessel Occlusion CADt Devices

[ Price : $8.95]

An FDA update clarifies the intended use of radiological computer-aided triage and notification devices for intracranial large ves...

Fentanyl Detection Kit Gains Clearance

[ Price : $8.95]

FDA clears a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human u...

Dismissal Sought in FDA-483 Anonymity Suit

[ Price : $8.95]

FDA says that a reverse-FOIA lawsuit seeking to shield an unnamed company attorneys identity in connection with a Form FDA-483 sho...

3rd Circuit Flunks FDA Again Over Illegal Generics

[ Price : $8.95]

The 3rd Circuit Court of Appeals agrees with a Pennsylvania federal court that FDA failed to state the offense under the law in ch...

Stratus Illegally Marketing Biologics: FDA

[ Price : $8.95]

FDA warns Stratus Biosystems that it is illegally marketing biological products whose manufacturing has significant deviations fro...

FDA Denies 2 Vanda Tasimelteon Petitions

[ Price : $8.95]

FDA says the Teva and Apotex generic forms of Vandas Hetlioz do not violate labeling requirements or raise safety concerns due to ...

FDA Approves Eyelid Mite Disease Drug

[ Price : $8.95]

FDA approves a Tarsus Pharmaceuticals NDA for Xdemvy (lotilaner ophthalmic solution) 0.25% for treating Demodex blepharitis, an ey...

CDRH Adds Device Sterilization Standards

[ Price : $8.95]

CDRH announces new standards recognized by the agency to improve medical device sterilization.