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Philips Respironics Recalls V60 Ventilators

[ Price : $8.95]

Philips Respironics recalls its V60 and V60 Plus ventilators that provide High Flow Therapy, due to a risk to the patients if the ...

Info Collection on Device Recall Authority

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority--21 CFR Par...

Comments Extended on Drug Security Guide

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Federal Register notice: FDA extends the comment period for a 6/4 notice about a draft guidance entitled Enhanced Drug Distributio...

CGMP Issues at Syntec Pharma

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FDA warns Syntec Pharma about CGMP deviations in its production of active pharmaceutical ingredients.

Abbott Imaging Software Platform Cleared

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FDA clears an Abbott 510(k) for its latest optical coherence tomography (OCT) imaging platform powered by the companys new Ultreon...

Clinical Hold Lifted on Novartis Gene Therapy

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FDA lifts a partial clinical hold against a Novartis investigational gene therapy OAV-101 intrathecal clinical trial for spinal mu...

Senate Subcommittee Gives FDA $200 Million Budget Boost

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A Senate appropriations subcommittee votes to advance FDAs fiscal year 2022 budget with a $200 million (6%) spending boost.

Patel Debarment Order for 1 Year

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Federal Register notice: FDA denies a request for a hearing submitted by Vithal K. Patel and issues an order debarring him for one...

Ngo Debarred for Five Years

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Federal Register notice: FDA denies Belen G. Ngos request for a hearing and is issuing an order debarring her for five years from ...

FDA Approves AstraZeneca Lupus Therapy

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FDA approves an AstraZeneca BLA for Saphnelo (anifrolumab-fnia) for treating adult patients with moderate to severe systemic lupus...