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FDA Study on Potential Changes for QT Cardiac Safety Studies

[ Price : $8.95]

An FDA co-designed study suggests that drug developers could conduct robust cardiac safety characterizations several years earlier...

FDAs First CLIA Waiver Goes to Syphilis Rapid Test

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FDA grants the first-ever Clinical Laboratory Improvement Amendments (CLIA) waiver for Veda Labs (Alencon, France) rapid screening...

ChemoCentryx Positive Phase 2 Data with Diabetic Nephropathy

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ChemoCentryx says a 52-week Phase 2 clinical trial involving its orally administered C-C chemokine receptor 2 antagonist CCX140 in...

FDA OKs MP Biomedicals HTLV Test

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FDA grants approval to MP Biomedicals for its MP Diagnostics Human T-Cell Lymphotropic Virus Blot 2.4, a Western Blot for HTLV con...

Court Orders Actavis to Continue Distributing Namenda

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New York Attorney General Eric T. Schneiderman wins a preliminary injunction against Actavis that requires the company to continue...

FDA Approves Sanofi Pasteurs Fluzone Quadrivalent

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FDA approves a Sanofi Pasteur supplemental BLA for Fluzone Intradermal Quadrivalent vaccine.

FDA Approves Lillys Cyramza for Lung Cancer

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FDA approves an Eli Lilly supplemental NDA to expand the approved use of Cyramza (ramucirumab) to treat patients with metastatic n...

Senators Introduce Dormant Therapies Act

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Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) have introduced the Dormant Therapies Act, a bill that will establish a new ...

Stakeholders Blast Device Classification Proposal

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Industry stakeholders say an FDA proposed rule on medical device classification exceeds the reforms spelled out in the FDA Safety ...

Comments Sought on Products Reporting Program Revisions

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Federal Register Notice: FDA seeks comments on a collection of information on revisions to the forms used in the FDA Medical Produ...