FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

MDR and QS Violations at Smiths Medical

[ Price : $8.95]

FDA warns Minneapolis-based Smiths Medical about Medical Device Reporting and Quality System violations in its work as a specifica...

De Novo Classification Rule Webinar

[ Price : $8.95]

FDA schedules a 12/14 Webinar on the medical device de novo classification process and its guidance document updates.

Feds Say Frenchman Made False Statements to FDA

[ Price : $8.95]

The Justice Department says a French national has been charged with making false statements to FDA to fraudulently obtain control ...

Pear Therapeutics Breakthrough for Alcohol-use App

[ Price : $8.95]

FDA grants Pear Therapeutics a breakthrough device designation for its reSET-A PDT (Prescription Digital Therapeutic) product cand...

Lledo Debarred Over Clinical Trial Wrongdoings

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Maytee Lledo from providing services in any capacity to a perso...

Laparoscopic Power Morcellation Containment is Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies the general laparoscopic power morcellation containment system into Class 2 (special contr...

Sagent Pharma Recalls Levetiracetam Over Sterility Concerns

[ Price : $8.95]

Sagent Pharmaceuticals recalls four lots of levetiracetam injection due to container closure integrity concerns.

FDA Regulated Recalls Surge: Sedgwick Index

[ Price : $8.95]

The Sedgwick Recall Index for the third quarter shows that both medical device and drug recalls surged.

FDA Extends Oelogel-S10 Review Date

[ Price : $8.95]

FDA extends for three months the PDUFA action date for Amryts NDA for Oleogel-S10 to treat cutaneous manifestations of junctional ...

LPAD Pathway Rarely Used: GAO Analysis

[ Price : $8.95]

The Government Accountability Office reports that the FDA limited population pathway for antibacterial and antifungal drugs has go...