FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

FDA Maintains High Bar for P13K Inhibitors

As a sign FDA is continuing to raise the bar on data needed to gain approval for a PI3K inhibitor, MEI Pharma and Kyowa Kirin decide to abandon develo...

latest-news-card-1
Human Drugs

FDA Developed New Covid Drug Surveillance: Study

CDER researchers describe Covid-19 drug safety surveillance lessons learned.

latest-news-card-1
Biologics

Team Biologics Needs More Staff, Training: Former FDAers

Three former FDA Team Biologics inspectors tell Politico inspections are being conducted by team members who do not have sufficient experience or trai...

latest-news-card-1
Medical Devices

Pass VALID Act Now: Former Commissioners

Former FDA commissioners Scott Gottlieb and Mark McClellan call on Congress to promptly pass the VALID Act to modernize FDA regulation of laboratory-d...

latest-news-card-1
Human Drugs

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

FDA posts a final guidance on pharmacokinetic-based criteria used to supporting alternative dosing programmed cell death receptor-1 or programmed cell...

latest-news-card-1
Federal Register

Selective Safety Data Collection Final Guidance

Federal Register notice: FDA makes available a final guidance entitled E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-A...

latest-news-card-1
Human Drugs

Contract Lab Valisure Relinquishes its Testing Prowess

Contract testing laboratory Valisure relinquishes its regulatory testing ability after a recent FDA inspection raised testing issues associated with t...

latest-news-card-1
Medical Devices

FDA Updates Endologix Endovascular Graft Safety

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

latest-news-card-1
Human Drugs

Clinical Hold Issues Outlined for Cholesterol Gene Therapy

FDA issues Verve Therapeutics a formal clinical hold letter that outlines the information required to resolve a hold that was placed 11/4 on VERVE-101...

latest-news-card-1
Medical Devices

FDA Confirms Survival Rate With Abiomeds Heart Device

FDA confirms the survival rate of Abiomeds Impella RP System that was required to undergo a post-approval study after being approved in 2017.