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Mixed Reality Device CGMP Inspection Success

[ Price : $8.95]

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

FDA Withdraws From Device Harmonization Group

[ Price : $8.95]

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

[ Price : $8.95]

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

Priority Review for Abeona Therapeutics BLA

[ Price : $8.95]

FDA accepts for priority review an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) for treating patients with recessi...

Guide on Covid-19 Drugs/Biologics

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Federal Register notice: FDA makes available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Trea...

Aldeyra Complete Response on Dry Eye NDA

[ Price : $8.95]

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Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications Fr...

Evive Bios Ryzneuta Approved by FDA

[ Price : $8.95]

FDA approves an Evive Biotech BLA for Ryzneuta (efbemalenograstim alfa), indicated to decrease the incidence of infection, as mani...