FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Figueroa Permanently Debarred by FDA

[ Price : $8.95]

Federal Register notice: FDA permanently debars Raidel Figueroa from providing services in any capacity to a person that has an ap...

Regeneron Prostate Cancer Trial Stops Enrollment

[ Price : $8.95]

Regeneron says it has discontinued enrollment in a Phase 1 prostate cancer study of REGN5678, which is studying the combination us...

FDA Floats AI Modeling to Help Assess Drug Safety

[ Price : $8.95]

FDA discusses a new drug safety initiative that aims to develop artificial intelligence models for toxicological endpoints that ar...

Nitrosamine Acceptable Intake Limits Guide

[ Price : $8.95]

FDA releases a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDS...

Mesoblast Sent Another Complete Response Letter

[ Price : $8.95]

FDA sends Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute...

Biosense Webster New Label on Cardiac Ablators

[ Price : $8.95]

FDA approves new labeling to permit several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy ...

Meeting on Study Disruptions During Emergencies

[ Price : $8.95]

Federal Register notice: FDA announces a 10/18-19 public meeting entitled Mitigating Clinical Study Disruptions During Disasters a...

Guide on User Fee Waivers for HIV Drugs

[ Price : $8.95]

Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Sin...

Guide on Antiretrovirals for HIV1 Under PEPFAR

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously...

DSCSA Can Lead to Drug Shortages: Reps

[ Price : $8.95]

A bipartisan group of 28 House members asks FDA about the potential for drug shortages if supply chain members cant meet the 11/27...