FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Class 2 for Upper Limb Tremor Stimulator

[ Price : $8.95]

Federal Register notice: FDA classifies the external upper limb tremor stimulator into Class 2 (special controls).

Teva Sues FDA Over Generic Restasis Exclusivity

[ Price : $8.95]

Teva asks a federal court to order 180-day exclusivity for its Restasis ANDA.

Walmarts Yiannis Named FDA Deputy Commissioner

[ Price : $8.95]

FDA commissioner Scott Gottlieb announces the appointment of Walmart executive Frank Yiannis as deputy commissioner for food polic...

Stakeholders Want More Device Accessories Reclassified

[ Price : $8.95]

Stakeholders ask for changes to an FDA list of medical device accessories proposed for down-classification to Class 1.

CDRH Surveillance/Enforcement on Promo Efforts

[ Price : $8.95]

A CDRH official says surveillance and enforcement concerns involving promotional or adverting efforts include unapproved devices, ...

Teva Sues FDA Over Generic Restasis Exclusivity

[ Price : $8.95]

Teva asks a federal court to order 180-day exclusivity for its Restasis ANDA.

FDA Clears MC3 Crescent Jugular Catheter

[ Price : $8.95]

FDA clears an MC3 510(k) for the Crescent Jugular Dual Lumen Catheter for use in extracorporeal membrane oxygenation.

FDA Wants Generic Drugs Harmonized Globally

[ Price : $8.95]

FDA commissioner Scott Gottlieb says the agency is seeking international harmonization of generic drug scientific and technical re...

Eisai Sales Rep Made False, Misleading Statements: OPDP

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion cautions Eisai about a sales representatives misleading presentation on the safety of ...

Class 2 for Herpes Virus Lesion Panel IVD

[ Price : $8.95]

Federal Register notice: FDA classifies the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into Class 2 ...