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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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Inova Diagnostics’ Assay Cleared by FDA

Inova’s test can help identify patients who are at severe risk of illness and often need aggressive immunosuppressive therapy.
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Indian Drugmaker Draws FDA Warning for Adulterated Products

The firm attributed out-of-specification and out-of-trend assay results for certain tablets to sampling preparation errors but didn’t provide any evidence to support the findings.

AETERNA ZENTARIS PRESENTED POSITIVE IN VIVO DATA ON ZEN-019, AN ORAL, LHRH ANTAGONIST PEPTIDOMIMETIC

KEYWORDS Daily International Pharma Alert
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AEterna Zentaris Inc. today announced that it presented Abstract No. P3-257 during a poster presentation entitled "ZEN-019, A Peptidomimetic from a New Class of Orally Active GnRH (LHRH) Antagonists," on Monday, June 26, 2006 in the Exhibit Hall of the Boston Convention & Exhibition Center in Boston, Massachusetts, during the 2006 Annual Meeting of the Endocrine Society.

Drug Newswire (http://www.drugnewswire.com/2696/)

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