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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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Appendix M of the NIH Guidelines: Reporting Requirements and Best Practices

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Congress

Stakeholders Urge Congress to Update Clinical Laboratory Diagnostics Legislation

The letter to lawmakers cites an urgent need to reform regulations covering laboratory developed tests and in vitro diagnostics.
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Seniors Paying More for Generics Through Medicare Part D, Study Finds

The higher cost sharing did not correspond with an increase in the underlying price of generic drugs, Avalere said.

NEOSE TECHNOLOGIES, INC. SHARES FALL AFTER STUDY START DELAYED BY FURTHER FDA QUESTIONS

KEYWORDS Daily International Pharma Alert
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Neose Technologies, Inc. today provided an update on its clinical development program for NE-180, the Company's long-acting, GlycoPEGylated erythropoietin for the treatment of anemia. The company has concluded the dosing and safety follow-up for its Phase I trial in Western Europe. Final analyses of pharmacokinetic data and other parameters are ongoing. NE-180 was generally well-tolerated at the doses tested, and the expected increases in reticulocytes and hemoglobin were observed in both the intravenous and subcutaneous dose groups.

BioSpace (http://www.biospace.com/news_story.aspx?StoryID=23922&full=1)

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