FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Fresenius/Formycon Stelara Biosimilar Approved

[ Price : $8.95]

FDA approves Fresenius Kabi and Formycons biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnsons referenced Stelara.

Cassidy Wants Info on Orange Book Listing Requirements

[ Price : $8.95]

Sen Bill Cassidy asks FDA to respond to questions about its decades-long failure to give Orange Book patent listing clarity to dru...

Diamond Chemical CGMP Violations

[ Price : $8.95]

FDA warns East Rutherford, NJ-based Diamond Chemical about CGMP violations in the production of finished drugs.

FDA Inspections Reorganization Effective 10/1

[ Price : $8.95]

FDA begins implementing a new model for FDA inspections as part of an agency-wide reorganization that was brought on by the 2022 i...

FDA to Study Drug Promotion in Talk Shows

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion says it will research how using an endorser to provide prescription drug informatio...

Info Collection on E-User Fee Payments

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic User Fee Payment Request Forms ...

Kezar Suspends Lupus Trial After 4 Deaths

[ Price : $8.95]

After four deaths were reported, Kezar Life Sciences suspends the enrollment of new patients and dosing of ongoing patients in its...

Device Performance Criteria for 4 Dental Devices

[ Price : $8.95]

Federal Register notice: FDA makes available four final device-specific guidance documents for the Safety and Performance Based Pa...

J&J Files sBLA for Darzalex Faspro

[ Price : $8.95]

Johnson & Johnson files a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a new indication combinat...

Smiths Medical Recalls ParaPac Ventilators

[ Price : $8.95]

Smiths Medical recalls (Class 1 device correction) its ParaPAC Plus P300 and P310 Ventilators due to inadvertent tidal volume knob...