FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Device Cybersecurity Guide Coming by 9/30: FDA

[ Price : $8.95]

FDA plans to finalize by 9/30 its draft guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Cont...

Eylea OKd After Fixing Inspection Findings

[ Price : $8.95]

Regeneron Pharmaceuticals wins FDA approval for high-dose Eylea HD (aflibercept) injection 8 mg after resolving inspection concern...

Califf to Put Pressure on Indian Drug Makers

[ Price : $8.95]

HHS secretary Xavier Becerra announces that FDA commissioner Robert Califf will be heading soon to India to meet with Indian regul...

Bortezomib Not Removed Over Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Accord Healthcares bortezomib solution was not withdrawn due to safety or effectivene...

FDA Debars Winne Over Testing Lab

[ Price : $8.95]

Federal Register notice: FDA denies a request for a hearing and permanently debars David Roy Winne from providing services related...

Anika Gains Rotator Cuff Implant Clearance

[ Price : $8.95]

FDA clears an Anika Therapeutics 510(k) for the Integrity Implant System, intended for use in augmenting an injured tendon to prom...

Veopoz OKd and Eylea Issues Fixed: Regeneron

[ Price : $8.95]

FDA approves a Regeneron Pharmaceuticals BLA for Veopoz (pozelimab-bbfg) for treating adult and pediatric patients one year of age...

Merck Touts Welireg in Kidney Cancer

[ Price : $8.95]

Merck says it will submit to FDA favorable data from its LITESPARK-005 Phase 3 trial evaluating Welireg (belzutifan) for treating ...

FDA Updates Warning on UV Wands

[ Price : $8.95]

FDA updates its list of ultraviolet wand products that may present a potential risk of injury.

GE Mobile Patient Monitor Cleared

[ Price : $8.95]

FDA clears a GE HealthCare 510(k) for its Portrait Mobile wireless and wearable monitoring device.