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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Procleix’s Zika Assay Earns FDA Approval for Use With Panther System

The assay is also approved to test plasma or serum samples to screen other living or dead organ donors and human cells, tissues and cellular and tissue-based products.

FDA Plans Study of Risk Information in Direct-to-Consumer Print Ads

The in-person study will consist of an hour-long 40-person pilot study, in addition to two hour-long studies with 200 voluntary participants each.

Home » FDA APPROVES DACOGEN FOR INJECTION

FDA APPROVES DACOGEN FOR INJECTION

MGI Pharma and SuperGen have reported that the FDA has approved Dacogen (decitabine) for injection.

Dacogen is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo, and secondary MDS. The company plans to make Dacogen commercially available during the second quarter of 2006.

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