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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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13th Annual FDA Inspections Summit

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FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

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Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

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SOPs and Policies for the 21st Century: Why Less is More

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Brexit and the Impact to Your Global Business Operations: What Life Sciences Companies Need…

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FDA’s New Biosimilars Plan: CBER’s New Policy and the Impact on Pharmaceutical Stakeholders

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FDA Clears Viseon’s Voyant System

The device allows the surgeon to change the depth of focus and view the surgical site on HD flat-panel display monitors.
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FDA Advisory Committee Nixes Trevena’s Opioid in Tight Vote

The FDA concluded there was insufficient evidence for a safety advantage compared to morphine.

VASOGEN REPORTS PRECLINICAL VP025 DATA

KEYWORDS Drug Pipeline Alert
A A

Vasogen has announced preclinical findings from its VP025 drug development program demonstrated a significant reduction of several pro-inflammatory cytokines in a preclinical model of diabetes and diabetic retinopathy, a common complication of diabetes that eventually results in the loss of vision.

In a preclinical model designed to develop diabetes, VP025 was shown to have a significant effect on reducing the expression, in the retina, of several pro-inflammatory cytokines including IL-1, IL-6, and MCP-1, which are associated with the initiation stages of diabetic retinopathy. Concurrently, the intramuscular administration of VP025 resulted in the increased expression of both IL-10 and TGF-beta, two potent anti-inflammatory cytokines.