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FDA Approves Another Breakthrough Drug Imbruvica

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FDA approves a second breakthrough-designated drug Pharmacyclics and Janssen Biotechs Imbruvica (ibrutinib) for treating patients...

Senate to Debate Compounding Bill

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Sen. Tom Harkin says the Senate will debate his Drug Quality and Security Act on oversight of drug compounding and a national drug...

Monitor Compliance Agreements for Enforcement Trends: Posting

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Policy and Medicine urges regulated industry to study new compliance integrity agreements to keep up with enforcement trends.

FDA OKs PresbiBio Phase 2 Trial of Microlens for Presbyopia

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FDA grants conditional approval to PresbiBio LLC for an IDE application to begin a Phase 2 trial of its Presbia Flexivue Microlens...

FDA Proposes Revised Procedures for New Labeling Info

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Federal Register Proposed rule: FDA proposes to revise procedures for approved drug or biological product holders to change labeli...

FDA Partnering with Mekong Region on Food, Drug Safety

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FDA commissioner Margaret Hamburg says her agency is working with Mekong Region counterparts on issues of food and drug safety.

Reviewers Back Tasimelteon Approval

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CDER medical reviewers tell the Peripheral and Central Nervous System Advisory Committee that they recommend approval of Vanda Pha...

GSK Darapladib Trial Fails to Meet Endpoint

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GlaxoSmithKline says its darapladib failed to meet the primary endpoint in a Phase 3 trial of its use in adults with chronic coron...

Nautilus Asks Cambia PREA Deferral Reconsideration

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Nautilus asks FDA to reconsider its request for a deferral of pediatric studies of its migraine analgesic Cambia.

FDA Clears IntelligentMDx C. difficile Assay

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FDA clears an IntelligentMDx 510(k) for its IMDx C. difficile for use with Abbotts m2000 assay.