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Merck sNDA for 1st Line Keytruda in Lung Cancer Approved

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FDA approves a Merck supplemental NDA for Keytruda (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, ...

FDA Draft Guide on Drugs for Women With Low Sexual Interest

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FDA releases a draft guidance on Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment that is inte...

Changes Asked in Real-World Evidence Guidance

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Stakeholders suggest improvements to an FDA draft guidance on using real-world evidence in medical device regulatory decisions.

Viracor-IBT Distributing Unapproved Zika Tests: FDA

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FDA says Viracor-IBT Laboratories is selling unapproved Zika tests.

Concerns Raised About UDI Draft Guidance

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Stakeholders air concerns about an FDA draft guidance on UDI label components.

FDA/CMS Formally Implement Parallel Review Program

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Federal Register Notice: FDA and CMS announce their intention to fully implement their joint parallel review pilot program.

FDA Urges Public to Report Device Regulatory Misconduct

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FDA urges the public and industry insiders to report regulatory misconduct against medical device manufacturers or individuals mar...

Inovio Pharma Phase 3 Trial on Clinical Hold

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FDA places a clinical hold on an Inovio Pharmaceuticals proposed phase 3 clinical program for VGX-3100, requesting additional data...

Public Meeting on Generic Drug User Fees: Correction

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Federal Register Notice: FDA corrects a 9/26 notice announcing a public meeting to discuss proposed recommendations for reauthoriz...

Eustachian Tube Balloon Dilation System is Class 2

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Federal Register Final Order: FDA classifies the Eustachian tube balloon dilation system into Class 2 (special controls).