FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Animal Drug Regs Amended for Approval Actions

[ Price : $8.95]

Federal Register notice: FDA amends the animal drug regulations to include application-related actions for new animal drug applica...

FDA Updates EUA Listing for Medical Devices

[ Price : $8.95]

Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for certain medical devices intended for use d...

Mesoblast Remestemcel-L BLA Resubmitted

[ Price : $8.95]

FDA accepts a Mesoblast BLA resubmission for remestemcel-L for treating children with steroid-refractory acute graft versus host d...

Updated Safety Alert on Breast Implant Cancer

[ Price : $8.95]

An FDA safety update indicates that an agency literature review has found reports of 19 squamous cell carcinoma cases in the scar ...

FDA Revokes 2 Covid-19 Tests

[ Price : $8.95]

Federal Register notice: FDA revokes the Emergency Use Authorizations issued for two Covid-19 diagnostics Babson Diagnostics for ...

FDA Accepts BioMarin Voxzogo New Indication sBLA

[ Price : $8.95]

FDA will review a BioMarin sBLA to expand the approved achondroplasia treatment indication for Voxzogo to include children under a...

Covis Willing to Voluntarily Withdraw Makena

[ Price : $8.95]

Covis Pharma says it is willing to work with CDER on an orderly withdrawal of Makena from the market.

FDAs Cancer Patient-Focused Glossary

[ Price : $8.95]

Six Oncology Center of Excellence staff members describe the process used in developing a new patient-focused glossary of cancer c...

USP Launches Nitrosamines Analytical Hub

[ Price : $8.95]

The United States Pharmacopeia launches its Nitrosamines Analytical Hub to help address the nitrosamine crisis in the U.S.

FDA Bioresearch Inspection Findings Out

[ Price : $8.95]

FDA annual inspection metrics from its Bioresearch Monitoring program show that the most common clinical investigator inspectional...