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FDA Debarment Order Against Ex-Insys Manager

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Richard M. Simon from providing services in any capacity to a p...

OPDP Core Launch Review Process Updated

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An 11/20 CDER Webinar will explain changes to the Office of Prescription Drug Promotion core launch review process.

Vaccine Electronic Safety Report Info

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FDA posts online information for vaccine manufacturers to submit safety reports electronically to CBER.

Armis Biopharmas Toe Implant Approved

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FDA approves Armis Biopharmas VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes fo...

Regenerative Cell Institute Illegally Marketing Cellular Products: FDA

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FDA says Regenerative Cell Institute in Las Vegas is illegally providing cellular products to treat many diseases and conditions.

FDA Clears EOGas 4 Ethylene Oxide Gas Sterilizer

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FDA clears an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing ...

FDA Approves Modified Definity for Echocardiograms

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FDA approves a Lantheus Holdings/Progenics Pharmaceuticals supplemental NDA for Definity Room Temperature (perflutren lipid micros...

FDA Delaying BMS Liso-Cel Action Date

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FDA delays the PDUFA action date to complete review of a BMS BLA for liso-cel to treat some large B-cell lymphomas due to the pand...

First At Home Covid Test Gets EUA

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FDA grants Lucira Health an Emergency Use Authorization for the first prescription molecular diagnostic test for Covid-19 that can...

Pfizer/BioNTech Filing Covid Vaccine EUA in Days

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Pfizer and BioNTech plan to submit within days an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b...