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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.

Events

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Sep 24

Drug Regulation in China: Updates, Key Issues and Common Challenges

Sep 25

The AI Revolution: What You Must Know About Medical Imaging Regulation

Sep 27

Using IT to Improve Data Integrity: Optimizing Your Compliance Joint IT/QA Programs

Sep 27

FDA and EU Inspections — The Mutual Recognition Agreement: What’s Next?

Oct 1

Advanced GMP Training: The Seven Essentials for Compliance

Oct 4

Transparency and the New Medical Device Reporting Rules: What to Do Now That ASR is Really Over

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Lax Quality Observed at Device Facility in China

The company failed to investigate a customer complaint about a malfunctioning device.
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Three Breast Cancer Drugs Pose Risks of Lung Inflammation, FDA Says

Possible symptoms include shortness of breath while resting or during low physical activity, the agency said.

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.