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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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Oct 23

13th Annual FDA Inspections Summit

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

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Nov 1

SOPs and Policies for the 21st Century: Why Less is More

Nov 1

Brexit and the Impact to Your Global Business Operations: What Life Sciences Companies Need…

Nov 7

FDA’s New Biosimilars Plan: CBER’s New Policy and the Impact on Pharmaceutical Stakeholders

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Matrix Surgical’s OmniPore Implants Cleared for Marketing

The company expects to launch additional variants in early 2019.
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AbbVie, Novartis Reach Deal on Humira Biosimilar

AbbVie reported Humira sales of $18.4 billion in 2017.

FDA APPROVES DACOGEN FOR INJECTION

KEYWORDS Drug Pipeline Alert
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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.