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FDA Accepts Medacs Treosulfan NDA Resubmission

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Medexus Pharmaceuticals says FDA has accepted for review its Medac licensors resubmitted NDA for treosulfan, indicated for combina...

FDA Reviewers Air Alzheimers Drug Issues

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FDA medical reviewer raise some issues about Lillys investigational Alzheimers drug donanemab for advisory committee members to co...

GAO Cites OTC Hearing Aid Issues

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The Government Accountability Office says stakeholder groups have identified issues with OTC hearing aids that need to be monitore...

Reps Seek Info for Next Generation Cures

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Reps. DeGette and Buchson ask for input on steps Congress can take to help develop the next generation of healthcare treatments.

Workshop on AI Use in Drug/Biologic Development

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FDA and the Clinical Trials Transformation Initiative announce an 8/6 hybrid public workshop on artificial intelligence in drug an...

Pediatric Orthopedic Device Innovation Lags: Research

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University of MissouriKansas City researchers say pediatric orthopedic device innovation lags substantially behind adult device i...

Diasorin Liaison Plex Assay Cleared

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FDA clears a Diasorin 510(k) for its Liaison Plex Yeast Blood Culture Assay for microbiological diagnosis of bloodstream infection...

FDA Places Hold on Biomea Diabetes Trials

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FDA places a clinical hold on Biomea Fusions Phase 1-2 clinical trials of its investigational covalent menin inhibitor BMF-219 in ...

FDA Denies Nautilus Glove Reconsideration Request

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FDA denies a Nautilus Gloves request that the agency not rescind its 510(k) clearance for nitrile exam gloves and instead allow th...

Questions on Alzheimers Drug Draft Guidance

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Two stakeholders provide comments and questions on the latest FDA draft guidance on developing drugs to treat early Alzheimers dis...