FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Diasorin Liaison Plex Assay Cleared

[ Price : $8.95]

FDA clears a Diasorin 510(k) for its Liaison Plex Yeast Blood Culture Assay for microbiological diagnosis of bloodstream infection...

FDA Places Hold on Biomea Diabetes Trials

[ Price : $8.95]

FDA places a clinical hold on Biomea Fusions Phase 1-2 clinical trials of its investigational covalent menin inhibitor BMF-219 in ...

FDA Denies Nautilus Glove Reconsideration Request

[ Price : $8.95]

FDA denies a Nautilus Gloves request that the agency not rescind its 510(k) clearance for nitrile exam gloves and instead allow th...

Questions on Alzheimers Drug Draft Guidance

[ Price : $8.95]

Two stakeholders provide comments and questions on the latest FDA draft guidance on developing drugs to treat early Alzheimers dis...

Medtronic Recalls Malfunctioning StealthStation Software

[ Price : $8.95]

Medtronic recalls (Class 1) five versions of its StealthStation S8 neurological navigation device after customer complaints about ...

Trexo Robotics Illegally Marketing Devices: FDA

[ Price : $8.95]

FDA warns Mississauga, Canada-based Trexo Robotics Holdings about QS issues in its illegal manufacturing and marketing of robotic ...

BIMO Electronic Submission Format Guidance

[ Price : $8.95]

FDA publishes a draft guidance outlining the standardized format for electronic submission of BLA, NDA, and selected supplements f...

Info Collection on Rx Drug Marketing

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Prescription Drug Marketing.

Guide on Practices Surrounding BIMO Inspections

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance for industry entitled Processes and Practices Applicable to Bioresea...

Drug Shortages at Decade High, Last Longer: USP

[ Price : $8.95]

A United States Pharmacopeia 2023 drug shortage report highlights four factors contributing to a decade-high level of shortages th...