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FDA Mulls Safety Signal on Intercepts Ocaliva

[ Price : $8.95]

FDA tells Intercept Pharmaceuticals that it is evaluating a newly identified safety signal regarding liver disorder for Ocaliva.

Griffo Botanicals Cited of Covid Product Claims

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FDA sends Griffo Botanicals (Petaluma, CA) a Warning Letter after reviewing the companys Web site and social media sites and deter...

FDA Should Improve Lab Safety Oversight: GAO

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The Government Accountability Office recommends five steps FDA should take to strengthen its oversight of safety in agency laborat...

Investigational Covid19 Convalescent Plasma, Correction

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Federal Register notice: FDA corrects a notice that published in the 9/21 Federal Register announcing the withdrawal of a final gu...

Consultants Advice on How to Talk to FDA

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The data intelligence consulting firm Govzilla posts information on how regulated companies should talk to FDA and listen when FDA...

X4 Pharma Fast Track Status for Mavorixafor

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FDA grants X4 Pharmaceuticals a Fast Track Designation for mavorixafor for treating adult patients with WHIM (Warts, Hypogammaglob...

FDA Awards $16 Million in Rare Disease Treatment Grants

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FDA awards $16 million in six grants to help in developing treatments for rare diseases.

FDA No Longer Reviewing Covid LDT Emergency Use Submissions

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CDRHs Timothy Stenzel tells a virtual town hall that under an HHS ruling FDA is declining to review new EUA submissions for Covid ...

Y-mAbs Therapeutics Gets Orphan/Rare Pediatric Status

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FDA grants Y-mAbs Therapeutics an orphan drug designation and rare pediatric disease designation for its antibody nivatrotamab and...

GenMark EUA for ePlex Respiratory Pathogen Panel

[ Price : $8.95]

FDA grants GenMark Diagnostics an Emergency Use Authorization for its ePlex Respiratory Pathogen Panel 2.