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FDA Warns on Overheating Philips CPAP Devices

[ Price : $8.95]

FDA issues a warning on Philips DreamStation 2 continuous positive airway pressure (CPAP) machines and their potential to overheat...

Biden to use Defense Production Act on Shortages

[ Price : $8.95]

President Biden says his administration will invoke the Defense Production Act to manufacture essential medicines in the U.S. to m...

Public Meeting on Clinical Study Quality

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FDA and the Duke-Margolis Center for Health Policy announce a hybrid (online/in-person) public meeting 1/31 on Building Quality in...

Mixed Reality Device CGMP Inspection Success

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Researchers say a hybrid pilot mock drug GMP inspection found that on-site investigators were able to interact with remote partici...

Aldeyra Complete Response on Dry Eye NDA

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FDA sends Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treatin...

Novartis Recalls 2 Sandimmune Lots

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Novartis recalls two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottl...

Comments Extended on Unapproved Use Guide

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Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications Fr...

FDA Withdraws From Device Harmonization Group

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FDA withdraws its membership in the 32-member medical device Global Harmonization Working Party after failing to persuade the orga...

Info Collection on GLP Requirements

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Federal Register notice: FDA sends to OMB an information collection extension entitled Good Laboratory Practice Requirements for N...

VariSoft Infusion Sets Recalled

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Unomedical recalls certain VariSoft Infusion Sets due to the risk that the devices connector may detach from the set.