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BLA Accepted for Treating Lung Cancer

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FDA accepts for review a Daiichi Sankyo and AstraZeneca BLA for datopotamab deruxtecan (Dato-DXd) for treating certain adult patie...

Guide on Device Small Business Qualification

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Medical Device User Fee Small Busine...

Covid Symptoms in Clinical Trials Final Guidance

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FDA publishes a new final guidance on assessing Covid-19-related symptoms in adults and adolescents who are subjects in clinical t...

FDA Real-World Evidence Guide Stirs Critics

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Five stakeholders make suggestions for changes to an FDA draft guidance on using real-world evidence in medical device regulatory ...

More Companies Should Join TAP: Shuren

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CDRH director Jeffrey Shuren urges more medical device companies to join the Total Product Lifestyle Advisory Program.

3 E&C Dems Urge FDA Issue Trial Diversity Guide

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Democratic leaders of the House Energy and Commerce Committee urge FDA to promptly issue the overdue draft guidance on drug and me...

FDA Posts Medtronic Endotracheal Tube Update

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FDA posts a Medtronic update on its NIM electromyogram endotracheal tubes, including actions to take in the event of airway obstru...

Alert on Smartwatches Measuring Blood Glucose

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An FDA safety alert warns about the risks related to using smartwatches or smart rings that claim to measure blood glucose levels ...

sBLA for Tecvayli OKd for Reduced Dosing

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FDA approves a Johnson & Johnson supplemental BLA for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg ever...

United Therapeutics Sues FDA Over Liquidia NDA

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United Therapeutics sues FDA over its decision to permit Liquidia to seek a second indication for its Yutrepia by amending its pen...