FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Acuitive Technologies Suture Anchor Cleared

[ Price : $8.95]

FDA clears an Acuitive Technologies 510(k) for its Citrefix Knotless Suture Anchor System with Citregen material technology, a bio...

Panel Meeting Scheduled for Janssen Covid Vaccine

[ Price : $8.95]

Federal Register notice: FDA announces a 2/26 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Jan...

Anemic FDA Ad Enforcement Seen

[ Price : $8.95]

Eye on FDA reports that the CDER Office of Prescription Drug Promotion continued its anemic enforcement level in 2020.

Lilly EUA for Combo Monoclonal Antibody Therapy

[ Price : $8.95]

FDA issues Eli Lilly an emergency use authorization for bamlanivimab and etesevimab administered together for treating mild to mod...

Fresenius Kabi Oncology Pleads Guilty in Records Case

[ Price : $8.95]

Fresenius Kabi Oncology pleads guilty and agrees to pay $50 million in fines and forfeitures for removing records showing violativ...

Smiths Medical Syringe Pump Recall is Class 1

[ Price : $8.95]

FDA classifies as Class 1 a recall of Smiths Medical Medfusion Syringe Pumps (Models 3500 and 4500) due to the risk of medication ...

Senators Want Pulse Oximeter Info

[ Price : $8.95]

Sens. Warren, Wyden, and Booker ask FDA for information on the efficacy of pulse oximeters when used with patients with darker ski...

FDA Dry Heat Bioburden Reduction Enforcement Policy Explained

[ Price : $8.95]

CDRH biomedical engineer Devashish Shrivistava analyzes on a Webinar a recent FDA enforcement guidance for bioburden reduction sys...

FDA OKs ERX Phase 1 Leptin Trials

[ Price : $8.95]

FDA authorizes additional Phase 1 studies of ERX Pharmaceuticals ERX1000 to treat obesity.

Genmab, Seagen BLA on Cervical Cancer Therapy

[ Price : $8.95]

Genmab and Seagen submit a BLA seeking accelerated approval for tisotumab vedotin, indicated for treating patients with recurrent ...