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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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May 31

FDA’s New Concept of Operations for Drug Inspections and Evaluations: What You Need to Do Today

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FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

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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.

FDA APPROVES CELGENE'S THALOMID

KEYWORDS Drug Pipeline Alert
A A

The FDA has approved Thalomid, manufactured by Celgene, to treat newly diagnosed multiple myeloma, a cancer of the bone marrow.

Thalomid (thalidomide) was approved for use in combination with another drug, dexamethasone, for multiple myeloma. It will be available in capsules in doses of 50, 100 and 200 mg.

Thalomid -- which has been associated with serious birth defects if taken during pregnancy -- has previously been approved to treat debilitating skin sores associated with erythema nodosum leprosum, an inflammatory complication of leprosy.

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