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Biosimilar User Fee Rates Set for FY 2023

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Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2023.

FDA Issues Abbott EUA for Monkeypox Test

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FDA issues Abbott Molecular an emergency use authorization for its Alinity m MPXV and its use in detecting the monkeypox virus.

Alnylam Gains Expanded Label for Oxlumo

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FDA approves an Alnylam Pharmaceuticals supplemental NDA to expand the label for Oxlumo (lumasiran).

FDA Wants Makena Withdrawn While New Trial Conducted

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In arguing for its market withdrawal, an FDA briefing document says Covis Makena is not effective and has known risks.

Fresenius Recalls Ivenix Infusion Pump

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Fresenius Kabi recalls its Ivenix Infusion Systems large volume pump software due to a software design issue.

Ways to Improve FAERS Signal Review

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Yale University researchers say FDA should consider three ways to enhance the timely and robust assessment of drug safety signals ...

Boston Cell Standards IHControls Panel Cleared

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FDA clears a Boston Cell Standards 510(k) for its IHControls panel (HER2/ER/PR) for evaluating breast cancers.

AATD Consortium Partnership Launched

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CDER and CBER partner with the Critical Path Institute to plan for a consortium to facilitate clinical development programs for al...

FDA Steps to Harmonize with HHS Common Rule

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Two FDA officials describe steps the agency is taking to harmonize its oversight of clinical trials with the HHS Common Rule on pr...

FDA Needs More Postmarket Commitment Authority: Study

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Researchers say Congress should consider giving FDA more authority to deal with companies that dont complete their postmarket comm...