The US Food and Drug Administration (FDA) has approved a liquid-based Papanicolaou test system for use in collecting and preparing cervical/vaginal specimens; a continuous monitoring system for detecting trends and tracking glucose level patterns in adults with diabetes mellitus; and a bioabsorbable coated mesh for use in the surgical repair and reinforcement of soft tissue.
Medscape
Simplifying Global Compliance
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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.
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.
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Lax Quality Observed at Device Facility in China
The company failed to investigate a customer complaint about a malfunctioning device.
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.
FDAnews Device Daily Bulletin
FDA APPROVALS: MONOPREP PAP TEST, DEXCOM STS, C-QUR
May 2, 2006
