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Gmp-inspection-preparation-checklist-130x160

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.
FDAnews Device Daily Bulletin

GE TRIALS FIRST PET IMAGING AGENT TO TRACK BLOOD VESSEL GROWTH IN CANCER

June 19, 2006
KEYWORDS FDAnews Device Daily Bulletin
A A

GE Healthcare, a division of the General Electric Company has begun a clinical study of a new chemical for use in positron emission tomography (PET) imaging that could be used to monitor angiogenesis, the formation of new blood vessels in tumours.

Medical Technology Business Europe (http://mtbeurope.info/news/2006/606014.htm)