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Janssen Pharma Files 2 sBLAs for Simponi Aria

[ Price : $8.95]

Janssen submits two supplemental BLAs for Simponi Aria (golimumab) for treating polyarticular juvenile idiopathic arthritis and ju...

Phillips Resumes Making Defibrillators Under Consent Decree

[ Price : $8.95]

FDA asks a federal court to lift portions of a consent decree affecting Royal Philips to allow the company to resume manufacturing...

Enforcement Discretion on Remote Digital Pathology Devices

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FDA posts a new guidance entitled Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (Cov...

FDA Safety Alert on Off-label Chloroquine

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FDA issues a safety alert on off-label hydroxychloroquine or chloroquine use for Covid-19 outside of a hospital setting or a clini...

Speed Covid Vaccine Approval Process: Representatives

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35 House members ask FDA and HHS to find ways to speed Covid-19 vaccine development and deployment.

FDA Guidance on Medical Imaging Products for Covid-19

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FDA issues an immediately-in-effect guidance to help increase the availability and capability of medical imaging products needed i...

Info Collection on Electronic Import Entries

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Federal Register notice: FDA sends to OMB an information collection revision for Imports and Electronic Import Entries.

2 Warning Letters on CBD Product Marketers

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FDA issues Warning Letters to two companies for illegally selling unapproved products containing cannabidiol that violate the Fede...

Stop Using Hydroxychloroquine at VA: DeLauro

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Rep. Rosa DeLauro says the VA should stop using its stores of hydroxychloroquine on Covid-19 patients given scientific guidance th...

Info Collection on Drug Supply Security

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Federal Register notice: FDA sends to OMB an information collection revision for drug supply chain security collections.