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Cardio Flow Orbital Atherectomy Device Cleared

[ Price : $8.95]

FDA clears a Cardio Flow510(k) for the companys FreedomFlow Orbital Atherectomy Peripheral Platform.

Final Guide on Remote Monitoring Devices

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devic...

2 Guides on Covid-19 Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws two guidances Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing...

Hygienic Labs Didnt Respond to FDA Data Requests

[ Price : $8.95]

FDA warns Denver, CO-based Hygienic Labs that it has not responded to multiple requests for records and information so the agency ...

BMS Seeking Approval of Subcutaneous Opdivo

[ Price : $8.95]

Bristol Myers Squibb says it will seek approval for a subcutaneous formulation of its Opdivo (nivolumab) for use in patients with ...

Revised Guide on Covid-19 Vaccines

[ Price : $8.95]

FDA posts a revised guidance entitled Development and Licensure of Vaccines to Prevent Covid-19.

Confusion Exists in RWD/RWE Definitions: Analysis

[ Price : $8.95]

Nine FDAers discuss the agencys use of real-world data and real-world evidence, and the confusion that exists on those terms and h...

Regenerative Medicine Consensus Standards Guide

[ Price : $8.95]

FDA publishes a guidance on CBERs voluntary consensus standards recognition program for regenerative therapy products.

Guide on Drug, Biologic Benefit/Risk Assessment

[ Price : $8.95]

FDA publishes a guidance on considerations about a drugs benefits and risks that the agency applies to certain premarket and postm...

SeaStar Breakthrough Status for Cytopheretic Device

[ Price : $8.95]

FDA grants SeaStar Medical Holding a breakthrough device designation for its cell-directed Selective Cytopheretic Device for use i...