FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Pass VALID Act Now: Former Commissioners

[ Price : $8.95]

Former FDA commissioners Scott Gottlieb and Mark McClellan call on Congress to promptly pass the VALID Act to modernize FDA regula...

Guide on PK-Based Criteria for PD1/PD-L1 Alt Dosing

[ Price : $8.95]

FDA posts a final guidance on pharmacokinetic-based criteria used to supporting alternative dosing programmed cell death receptor-...

Selective Safety Data Collection Final Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled E19 A Selective Approach to Safety Data Collection in Speci...

Contract Lab Valisure Relinquishes its Testing Prowess

[ Price : $8.95]

Contract testing laboratory Valisure relinquishes its regulatory testing ability after a recent FDA inspection raised testing issu...

FDA Updates Endologix Endovascular Graft Safety

[ Price : $8.95]

FDA updates a January safety communication about the use of Endologix AFX endovascular grafts for treating patients with abdominal...

Clinical Hold Issues Outlined for Cholesterol Gene Therapy

[ Price : $8.95]

FDA issues Verve Therapeutics a formal clinical hold letter that outlines the information required to resolve a hold that was plac...

FDA Confirms Survival Rate With Abiomeds Heart Device

[ Price : $8.95]

FDA confirms the survival rate of Abiomeds Impella RP System that was required to undergo a post-approval study after being approv...

Firms Seek EUA for Omicron Vaccine in Young Children

[ Price : $8.95]

Pfizer and BioNTech file an application seeking an emergency use authorization for their Omicron BA.4/BA.5-adapted bivalent Covid-...

Guide on Bioequivalence Statistical Approaches

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Establishing Bioequivalence.

Novartis Seeking Expanded Pluvicto Use

[ Price : $8.95]

Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), for slowing dise...