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Covid EUA Listing Updated

[ Price : $8.95]

Federal Register notice: FDA updates its listing of Emergency Use Authorizations (EUAs) for use during the COVID-19 pandemic to re...

Votrient Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Novartis Votrient (pazopanib hydrochloride) tablets, 400 mg, were not withdrawn from ...

Comments Extended on Device Remanufacturing Guide

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Federal Register notice: FDA extends the comment period for a 6/24 notice on a draft guidance entitled Remanufacturing of Medical ...

FDA Joins More Device Collaborative Communities

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FDA says it has joined several additional medical device collaborative communities.

PharmaTher Orphan Status for Ketamine in ALS

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FDA grants PharmaTher Holdings an orphan drug designation for ketamine and its use in treating amyotrophic lateral sclerosis.

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Federal Register notice: FDA extends the comment period for a 6/4 notice about a draft guidance entitled Enhanced Drug Distributio...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