FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Agilent GenetiSure Dx Postnatal Assay Cleared

[ Price : $8.95]

FDA clears an Agilent Technologies 510(k) for the GenetiSure Dx Postnatal Assay, a comparative genomic hybridization assay for dia...

Class 1 Recall of Leonard Lang Defibrillation Electrodes

[ Price : $8.95]

FDA rates as Class 1 a Leonard Lang recall of two Skintact multifunction defibrillation electrode models due to a connector compat...

Wound-Healing Study Misses Endpoints

[ Price : $8.95]

Amicus Therapeutics says top-line Phase 3 ESSENCE study data show its SD-101 wound-healing agent did not meet primary or secondary...

Cancer R&D Study Draws Advocate Fire

[ Price : $8.95]

Industry advocates challenge conclusions in a JAMA Internal Medicine analysis of the cost and potential revenue involved in develo...

Draft PQ/CMC Standardization Concerns Raised

[ Price : $8.95]

Drug companies say FDA should do more work on its draft document on standardization of pharmaceutical quality and chemistry, manuf...

FDA Panel Backs Warning on Gadolinium-based Contrast Agents

[ Price : $8.95]

FDAs Medical Imaging Drugs Advisory Committee votes to recommend a warning about gadolinium retention for gadolinium-based contras...

Woodcock Supports Reforms to OTC Monograph Program

[ Price : $8.95]

CDER director Janet Woodcock tells a House Energy and Commerce Health Subcommittee hearing that the current monograph system for o...

Cardio Drug Approval Rates Drop 52% in 30 Years: Analysis

[ Price : $8.95]

A Tufts Center for the Study of Drug Development analysis finds that the FDA approval rate for cardiovascular drugs has dropped 52...

CGMP Violations at HomeoCare Laboratories

[ Price : $8.95]

FDA warns HomeoCare Laboratories about CGMP violations in its production of three misbranded homeopathic drugs.

Dynavision D2 Adulterated and Misbranded: FDA

[ Price : $8.95]

FDA warns Dynavision that its D2 device is adulterated and misbranded and fails to conform to Quality System regulation requiremen...