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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.

TEIJIN, SATO TO COLLABORATE ON PSORIASIS TREATMENT

KEYWORDS Daily International Pharma Alert
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Japan's Teijin Pharma and Sato Pharmaceutical will begin marketing Bonalfa lotion (tacalcitol), an ethical agent for treating psoriasis vulgaris, the companies announced.

Bonalfa is a new formulation of Bonalfa ointment, which is currently co-promoted by the two companies. Tacalcitol, which was initially discovered by Teijin, is activated vitamin D3.

Indicated for the treatment of keratosis, Tacalcitol is available for sale in approximately 30 countries worldwide. The two companies aim to generate a combined total of $7 million in sales per year by 2008.

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