FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Takeda Priority BLA for Clotting Disorder

[ Price : $8.95]

FDA accepts for priority review a Takeda BLA for TAK-755, an enzyme replacement therapy for treating congenital thrombotic thrombo...

Prothena Adds Ex-FDA Neuroscience Head to Board

[ Price : $8.95]

Prothena says it has appointed former CDER Office of Neuroscience director Billy Dunn to its board of directors.

Attorney Sues FDA to Keep Name Off FDA-483

[ Price : $8.95]

An attorney who works for a company regulated by FDA asks the DC federal court to stop the agency from publishing the attorneys na...

Pharmedica CGMP Violations Result in Plant Shutdown

[ Price : $8.95]

Phoenix, AZ-based Pharmedica USA tells FDA it will stop all drug production and distribution after the agency finds CGMP violation...

Tack Endovascular Device Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for Intact Vasculars Tack ...

Ipca Laboratories FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with three observations issued following an April inspection at the Ipca Laboratories drug manufactu...

FDA Issues with Sea-Long Medical Treatment Hoods

[ Price : $8.95]

FDA warns Waxahachie, TX-based Sea-Long Medical Systems about multiple Quality System regulation violations in its production of m...

Bespoke Gene Therapy Portfolio has 8 Diseases

[ Price : $8.95]

The Bespoke Gene Therapy Consortium, of which FDA is a member, chooses eight rare diseases for a clinical trial portfolio intended...

Let Compounders Help with Drug Shortages: Op-Ed

[ Price : $8.95]

The Alliance for Pharmacy Compounding calls for changes to federal law to allow compounding pharmacies to help address temporary d...

Did Recarbrio Approval Break FDA Rules?

[ Price : $8.95]

A BMJ investigation questions how FDA approved Mercks antibiotic Recarbrio in 2019 since it did not appear to meet agency requirem...