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CGMP Violations in Kari Gran Inspection

[ Price : $8.95]

FDA warns Seattle, WA-based Kari Gran, Inc., about CGMP violations and data integrity issues in its production of finished drugs.

FDA Maintains High Bar for P13K Inhibitors

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As a sign FDA is continuing to raise the bar on data needed to gain approval for a PI3K inhibitor, MEI Pharma and Kyowa Kirin deci...

FDA Developed New Covid Drug Surveillance: Study

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CDER researchers describe Covid-19 drug safety surveillance lessons learned.

Team Biologics Needs More Staff, Training: Former FDAers

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Three former FDA Team Biologics inspectors tell Politico inspections are being conducted by team members who do not have sufficien...

Firms Seek EUA for Omicron Vaccine in Young Children

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Pfizer and BioNTech file an application seeking an emergency use authorization for their Omicron BA.4/BA.5-adapted bivalent Covid-...

Guide on Bioequivalence Statistical Approaches

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Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Establishing Bioequivalence.

Novartis Seeking Expanded Pluvicto Use

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Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), for slowing dise...

Guide on Selective Drug Safety Data Collection

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FDA posts a final guidance entitled E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post...

FDA Accepts Protalix, Chiesi Fabry Disease BLA Resubmission

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FDA accepts for review a Protalix BioTherapeutics and Chiesi BLA resubmission for PRX102 (pegunigalsidase alfa) for treating adult...

Draft Guide on ANDA Pre-inspection Correspondence

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Federal Register notice: FDA makes available a revised draft guidance entitled ANDAs: Pre-Submission Facility Correspondence Relat...