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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FDA publishes a draft guidance outlining the standardized format for electronic submission of BLA, NDA, and selected supplements f...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Federal Register notice: FDA makes available a draft guidance for industry entitled Processes and Practices Applicable to Bioresea...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...

Panel Backs JN.1 Variant-Targeted Covid Vaccine

[ Price : $8.95]

An FDA advisory committee unanimously votes to recommend that Covid-19 vaccine makers formulate their upcoming fall shots to provi...

Amgen: Positive Data on Uplizna in Ig G4 Disease

[ Price : $8.95]

Amgen announces positive data from its Phase 3 clinical trial (MITIGATE) evaluating the efficacy and safety of Uplizna (inebilizum...

Streamline and Update Biosimilar Development: Council

[ Price : $8.95]

The Biosimilars Council calls on FDA to eliminate unnecessary clinical efficacy studies as part of streamlining the biosimilar dev...

BIMO Processes and Practices Guidance

[ Price : $8.95]

FDA publishes a draft guidance on processes and practices for Bioresearch Monitoring inspections.