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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...

Hamilton Medical Ventilators Recalled

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Hamilton Medical recalls its Hamilton-C1, T1, MR-1 ventilators because the capacitators may leak electrolyte fluid onto the ventil...

Courts Could Cut FDA Labeling Enforcement: Avorn

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Harvard Medical School professor Jerry Avorn says recent court decisions banning compelled speech could be interpreted to stop FDA...

FCA Cases Look at Cybersecurity: Attorneys

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Seven Gibson Dunn attorneys say the government is pursuing False Claims Act cases involving cybersecurity claims by device manufac...

BrainStorm Pulls NurOwn BLA

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BrainStorm Cell Therapeutics says it is withdrawing a BLA for its NurOwn ALS treatment technology and will work with FDA on a path...

FDA Posts 6 Approved Info Collections

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Federal Register notice: FDA posts a list of six information collections that have been approved by OMB.