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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.

Events

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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.

ISTA PHARMA BEGINS CLINICAL TRIALS OF XIBROM

KEYWORDS Drug Pipeline Alert
A A

ISTA Pharmaceuticals is initiating Phase III clinical trials of once-daily formulation of Xibrom for the treatment of ocular pain and inflammation following cataract surgery.

The FDA has already approved the twice-daily Xibrom for the treatment of ocular inflammation and reduction of ocular pain following cataract surgery.