FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Org. Structure for CDRH Strategic Group

[ Price : $8.95]

Federal Register notice: FDA announces a modification to the organizational structure of CDRHs Office of Strategic Patnerships and...

Panel to Discuss IVD Reclassifications

[ Price : $8.95]

Federal Register notice: FDA announces a 9/7-8 Medical Devices Advisory Committee Microbiology Devices Panel meeting that will dis...

Phillips Recalls Trilogy EVO Ventilators

[ Price : $8.95]

Philips Respironics recalls its Trilogy Evo, Evo O2, EV300, and Evo Universal ventilators after detecting dust and dirt in the air...

FDA OKs Pfizer Multiple Myeloma Drug

[ Price : $8.95]

FDA gives Pfizer accelerated approval for Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 ...

Biocon Malaysia Plant Hit with 8-item 483

[ Price : $8.95]

FDA issues Biocon an eight-item Form FDA-483 after an inspection last month at the firms Johor, Malaysia manufacturing facility ci...

Guide on Off-the-Shelf Software in Devices

[ Price : $8.95]

FDA posts a final guidance entitled Off-The-Shelf Software Use in Medical Devices.

Astellas sNDA Filed for Pediatric Cresemba

[ Price : $8.95]

FDA accepts for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), an azole antifungal drug for tr...

Ceribells ClarityPro For Detecting Seizures

[ Price : $8.95]

FDA clears a Ceribell 510(k) for its new software ClarityPro for diagnosing electrographic status epilepticus in adults.

FDA Warning on 15 Universal Meditech Tests

[ Price : $8.95]

FDA warns the public not to use 15 tests manufactured by Universal Meditech after the company notified the agency that it has stop...

FDA On Parametric Release for Sterile Drugs

[ Price : $8.95]

FDA addresses whether parametric release is an appropriate control strategy for sterile drug products that are not terminally ster...