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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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Oct 23

13th Annual FDA Inspections Summit

Oct 30

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

Oct 30

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

Nov 1

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

Nov 1

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

Nov 7

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

Editor's Picks

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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.

CELSION REPORTS THERMODOX DATA

KEYWORDS Drug Pipeline Alert
A A

Celsion has reported data on its trial of ThermoDox, a proprietary heat-activated liposome containing doxorubicin HCI.

Queen Mary Hospital in Hong Kong has begun to participate as an additional site in the company's ongoing Phase I dose-escalation study investigating the use of ThermoDox, in combination with radiofrequency ablation to treat liver cancer. Together with a U.S. site -- the National Cancer Institute in Bethesda, Md. -- 14 patients have now been treated in the study, at single doses as high as 50 mg per meter squared.