FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDAs Whole-of-Government Approach to Illicit Products

[ Price : $8.95]

FDA officials say the agency is taking a whole-of-governments approach to combating the entry of illicit healthcare products into ...

FDA Clears Viz.ai Algorithm

[ Price : $8.95]

FDA clears a Viz.ai algorithm to give the ratio between right and left ventricle diameters in a patients heart for use in pulmonar...

Former Pharmatech CEO Gets 37 Months in Jail

[ Price : $8.95]

A Florida federal judge sentenced the former CEO of Pharmatech to 37 months in federal prison after he pled guilty to several char...

Ascendis NDA for Hypoparathyroidism Therapy

[ Price : $8.95]

Ascendis Pharma files an NDA for TransCon PTH, an investigational prodrug designed to restore parathyroid hormone (PTH [1-34]) to ...

FDA Observations from 3 Biocon Biologics Inspections

[ Price : $8.95]

FDA issues a form FDA-483 with multiple inspection observations to Indias Biocon Biologics following three inspections at manufact...

Cue Health Seeks De Novo for At-Home Flu Test

[ Price : $8.95]

Cue Health files a de novo marketing submission for its Cue Flu Molecular Test for at-home and point-of-care use.

GDUFA Research Supports Generic Drug Development

[ Price : $8.95]

The FDA FY 2021 GDUFA Science and Research Outcomes Report demonstrates how GDUFA research projects have contributed to the develo...

FDA, C-Path Exploring Lysosomal Diseases Group

[ Price : $8.95]

FDA says it is partnering with the Critical Path Institute to explore creating a Lysosomal Diseases Consortium as part of the Acce...

eCential Robotics Bone Surgical System Cleared

[ Price : $8.95]

FDA clears an eCential Robotics 510(k) for its 3D imaging, navigation and robotics guidance system for use in bone surgical proced...

Respironics Troubles Broaden as it Pays $24 Mil. Over False Claims

[ Price : $8.95]

As it negotiates a consent decree over its ventilators and other airway devices with the Department of Justice (DoJ), the company ...