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Investigational Covid19 Convalescent Plasma, Correction

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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.

Regeneron Seeks EUA Request for Trumps Covid Cure

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Regeneron seeks an emergency use authorization for its experimental antibody cocktail that president Trump has called a coronaviru...

Lilly Seeking Neutralizing Antibody Monotherapy EUA

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Lilly asks FDA for an EUA for a monoclonal antibody used in Covid-19 monotherapy.

FDA Chief Counsel on New Enforcement Precedent

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FDA chief counsel Stacy Cline Amin tells FDLI that the Covid-19 emergency has offered the agency an opportunity to set a new legal...