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FDA False Results Alert on Thermo Fisher Covid Tests

[ Price : $8.95]

FDA alerts clinical laboratory staff and health care providers about a risk of false results with Thermo Fisher Scientific TaqPath...

Myovant Sciences NDA for Uterine Fibroid Drug

[ Price : $8.95]

FDA accepts for review a Myovant Sciences NDA for its once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1....

Genentech Optic Nerve Rare Disease Drug Approved

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FDA approves a Genentech BLA for Enspryng (satralizumab-mwge) for treating neuromyelitis optica spectrum disorder in adults with a...

Bone Growth Stimulator Proposed Reclassification

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Federal Register notice: FDA proposes to reclassify non-invasive bone growth stimulators from postamendments Class 3 devices into ...

Untitled Letter Objects to Web Claims by Cell Therapy Firm

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CBERs Office of Compliance and Biologics Quality sends East West Health Solutions (Lake City, UT) an untitled letter based on a re...

Guide on ClinicalTrials.gov Civil Money Fines

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FDA issues a final guidance entitled Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.

FDA Amends 9/15 Pediatric Panel Meeting

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Federal Register notice: FDA amends a 7/23 notice about a 9/15 Pediatric Advisory Committee meeting.

2 Device Guides for Performance-based Pathway

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Federal Register notice: FDA makes available two final device-specific guidance documents for its Safety and Performance Based Pat...

FDA Device Shortage List During Covid-19

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FDA posts a device shortage list of products determined to be in short supply during the Covid-19 pandemic.

Appeals Court Rejects Bard Preemption Defense

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The 9th Circuit Court of Appeals rejects device preemption arguments from C.R. Bard in a product liability lawsuit involving the c...