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NIH Stops Convalescent Plasma Trial

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The National Institutes of Health (NIH) halts a clinical trial evaluating Covid-19 convalescent plasma in treating emergency depar...

Info Collection on GMPs for Finished Drugs

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Federal Register notice: FDA seeks comments on an information collection extension entitled Current Good Manufacturing Practice fo...

FDA Warns HealthQuilt on Clinical Trial Issues

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FDA warns HealthQuilt about objectionable conditions in its role as a clinical trial investigator.

FibroGen Hit with Late Panel Meeting Requirement

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FDA unexpectedly sends FibroGen and partner AstraZenecas NDA for chronic kidney disease anemia drug roxidadustat to its Cardiovasc...

Companies Push FDA to Solve Inspection Delays: Report

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Politico details drug industry pressure on FDA to find a way to conduct facility inspections despite the pandemic.

Merck Withdraws Keytruda Accelerated Indication

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Merck withdraws a Keytruda (pembrolizumab) indication for treating patients with metastatic small cell lung cancer with disease pr...

Changes in ViiV Triumeq, Dovato Labels

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FDA approves labeling changes for ViiVs Triumeq and Dovato.

Info Collection on Stakeholder Behavioral Research

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Federal Register notice: FDA sends to OMB a new information collection entitled Generic Clearance for Data To Support Cross-Center...

Bioventus Paying $3.6 Million for False Claims Violations

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The Justice Department says Bioventus is paying over $3.6 million to resolve allegations of violating the False Claims Act through...

FDA Clears Relivion System for Migraine Treatment

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FDA clears the Neurolief Relivion system for migraine treatment.