FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Use Preemption in Failure-to-Market Cases: PRI

[ Price : $8.95]

A Pacific Research Institute white paper makes the case for a preemption defense in failure-to-market cases brought under state la...

Court Threatens Practice of Medicine Defense: Attorneys

[ Price : $8.95]

Cooley attorneys say a recent 4th Circuit Court of Appeals decision threatens the practice of medicine defense, giving FDA an addi...

Breakthrough Status for Mortality Prognosticator Tool

[ Price : $8.95]

FDA grants Onc.AI a breakthrough device designation for its Serial CT Response Score AI model, which the company describes as an a...

Medline Catheter Recall is Class 1

[ Price : $8.95]

FDA says the Medline Industries recall of integrated arterial catheters is Class 1.

Trump to Fire Thousands of HHS Workers: Report

[ Price : $8.95]

Mainstream media reports based on anonymous sources say the White House is preparing an order to require HHS to fire a percentage ...

Cancer Drug Tabloid ANDA Restrictions Sought

[ Price : $8.95]

A Buchanan Ingersoll petition asks FDA to maintain restrictions on cancer drug Tabloid ANDAs that are in the applicable product-sp...

Fast Track Status for Crohns Imaging Agent

[ Price : $8.95]

FDA grants Bracco Imaging a fast-track designation for its BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injecti...

Diabetes Device Smartphone Alerts Malfunctioning: FDA

[ Price : $8.95]

An FDA safety alert on certain diabetes devices that rely on a smartphone to deliver critical safety alerts warns that these may m...

More States Want to Import Drugs: Bloomberg

[ Price : $8.95]

A Bloomberg Law report says New York is the latest state to indicate an interest in the FDA pathway to import lower-cost drugs fro...

Ziftomenib NDA Due in 2nd Quarter: Kura/Kyowa

[ Price : $8.95]

Kura Oncology and Kyowa Kurin say they expect to submit a ziftomenib NDA to FDA in the second quarter of 2025.