FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

FDA Clears Smiths Medical Medfusion Infusion Pump

[ Price : $8.95]

FDA clears a Smiths Medical 510(k) for its new Medfusion 4000 wireless syringe infusion pump with the PharmGuard infusion manageme...

FDA Explores 'Mechanism' for Reporting Drug Shortages

[ Price : $8.95]

FDA examines developing a mechanism for manufacturers to report impending supply disruptions and discontinuation of drugs, which c...

FDA 'Orphan' Status for Hodgkin's Drug

[ Price : $8.95]

FDA grants 4SC AG an orphan drug designation for its lead oncology compound resminostat in Hodgkin's lymphoma.

Embattled MelaFind Device Gains 'Approvable' Letter

[ Price : $8.95]

FDA sends a PMA approvable letter to Mela Sciences for its non-invasive melanoma diagnostic scanner, MelaFind,which has been in li...

No FDA Ruling on Blood Clots Associated with Pill

[ Price : $8.95]

FDA says it has not yet reached a conclusion about the potential increase blood clot risk associated with the use of drospirenone-...

FDA Mulls Help on Antibiotics Development: Woodcock

[ Price : $8.95]

CDER director Janet Woodcock says the agency is considering options to ease the development path for antibiotics.

Soliris New Indication for Rare Blood Disease

[ Price : $8.95]

FDA approves an Alexion Pharmaceuticals BLA for Soliris (eculizumab) for treating all pediatric and adult patients with atypical h...

FDA, Industry Reach Agreement on Biosimilar Fee Goals

[ Price : $8.95]

FDA and industry stakeholders reach tentative agreement on proposed performance goals for a 351(k) biosimilars user fee program.

Guidance on Reproductive/Developmental Toxicities

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance on integrating study results to assess concerns for reproductive and developmenta...

Aeolus Seeks Orphan Status for Radiation-exposure Drug

[ Price : $8.95]

Aeolus Pharmaceuticals submits an orphan drug application with FDA for AEOL 10150 for treating delayed effects of acute radiation ...