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Biocompatibility Testing Labs Falsified Data: FDA

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FDA says it will reject all data coming from biocompatibility testing labs Mid-Link Technology Testing and Sanitation & Environmen...

Serious Research Issues at United Health Products: FDA

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FDA warns Mt. Laurel, NJ-based United Health Products about serious violations in its clinical study of the CelluSTAT absorbable h...

Moderna Withdraws Pending BLA for Flu/Covid Vaccine

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Moderna, at FDAs urging, voluntarily withdraws a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate.

QS Violations in NeuroSync Inspection

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FDA warns Holliston, MA-based NeuroSync about Quality System regulation and other violations in its manufacturing of the Eye-Sync ...

Ethicon Endo-Surgery Recalls Surgical Stapler

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Johnson & Johnsons Ethicon Endo-Surgery recalls its Endopath Echelon Vascular White Reload for Advanced Placement Tip surgical sta...

Microspecialties Quality System Issues

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FDA warns Middletown, CT-based Microspecialties about Quality System violations in its work as a contract manufacturer of several ...

Expand mRNA Covid Vaccine Warnings: FDA

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FDA tells Pfizer and Moderna to strengthen the Warnings in their Covid-19 vaccines related to a possible adverse heart effect in y...

Bipartisan Bill to Codify Trump Drug Price Order

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Four House members introduce bipartisan legislation to legalize major provisions in President Trumps drug pricing executive order....

Panel is Split on UroGens Bladder Cancer Drug

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FDAs Oncologic Drugs Advisory Committee offers a split vote on whether UroGen Pharmas NDA for mitomycin intravesical solution demo...

Zynex Files 510(k) for CO-Oximeter Device

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Zynex files a 510(k) for its NiCO, Noninvasive CO-Oximeter device that relies on the companys laser technology.