FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Extends Review of Pfizer Growth Hormone

[ Price : $8.95]

FDA extends by three months the review of a Pfizer/Opko Health BLA for somatrogon, a once-weekly long-acting recombinant human gro...

FDA Revises Authorizations of Some Covid Tests

[ Price : $8.95]

FDA requires additional conditions of authorization for many molecular, antigen, and serology Covid tests to keep up with emerging...

Panel to Discuss 2 Accelerated Approval NDAs

[ Price : $8.95]

Federal Register notice: FDA announces a 12/2 Oncologic Drugs Advisory Committee meeting that will panel hear certain updates on N...

Cordis Recalls Angiographic Catheter

[ Price : $8.95]

Cordis recalls its Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands due to the potential for the bands to...

Suspend Vitamin B6 Sales: Emery Pharma Petition

[ Price : $8.95]

Emery Pharma asks FDA to recall and suspend sales of vitamin B6 and take other regulatory actions.

10 Observations in Greenpark FDA-483

[ Price : $8.95]

FDA releases an FDA-483 with 10 observations from an inspection at Prescription Labs Inc.

IntegraDose Compounding Recalls 11 Cefazolin Lots

[ Price : $8.95]

IntegraDose Compounding Services recalls nine lots of antibiotic cefazolin 2g in 20 mL syringes for injection and two lots of cefa...

Reverse CA Decision Punishing Scientific Speech: WLF

[ Price : $8.95]

Washington Legal Foundation says the California Court of Appeals should reverse a trial court decision imposing $344 million in ci...

Genesis Medical Sellng Unapproved Adipose Cellular Products: FDA

[ Price : $8.95]

FDA cautions Genesis Medical Center that it is marketing unapproved cellular and exosome products.

AdvaMed Comments on FDA Device Remanufacturing Guidance

[ Price : $8.95]

AdvaMed says an FDA draft guidance on remanufacturing of medical devices should clarify the difference between remanufacturing and...