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15 Observations in Qualgen FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with 15 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing facility.

FDA Orders Partial Clinical Hold on BioCryst Therapy

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FDA issues a partial clinical hold on BioCryst clinical trial of its oral Factor D inhibitor, BCX9930 due to observed elevations i...

Info Collection on Antimicrobial Animal Drug Reporting

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Federal Register notice: FDA sends to OMB an information collection extension entitled Antimicrobial Animal Drug Distribution Repo...

Psychiatrist Blasts Clozapine REMS

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Psychiatrist Brian Barnett says FDA should remove itself from neutrophil monitoring requirements for patients on clozapine and lea...

Glycemic Control Device Guidance

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FDA publishes a guidance with recommendations for feasibility and early feasibility studies in medical devices intended to improve...

User Fee Bill Aims to Correct Court Decisions

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A House Energy and Commerce Committee legislative package to reauthorize FDA user fee agreements aims to address agency predicamen...

Guide on Radiolabeled Mass Balance Studies

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Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Human Radiolabeled...

FDA Clears Dental Caries AI Detector

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FDA clears a VideaHealth 510(k) for its Videa Caries Assist, an artificial intelligence-powered dental caries (cavity) detection a...

FDA Limits Use of Janssen Vaccine Due to Clot Risk

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FDA limits the emergency use authorization of Janssens Covid-19 vaccine to certain individuals 18 years of age and older due to th...

Correlating Device Inspections with Warning Letters

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Attorney Bradley Thompson uses data analysis to determine medical device inspection observations that more frequently are associat...