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FDA Clears Sysmex Hematology Analyzers

[ Price : $8.95]

FDA clears the Sysmex XN-series hematology analyzers that include a test to help diagnose thrombocytopenia.

FDA Close-out Letter for Merit Medical Inspection

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FDA ssues Merit Medical Systems an inspection close-out letter telling the company that it has adequately addressed the violation ...

FDA Posts September Animal Drug Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect September approval actions and sponsorship changes.

Temple Wants to Review Failed Drug Development Programs

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CDER deputy director for clinical science Bob Temple says his Center is interested in reviewing data from failed drug development ...

Premarket Device Surveillance Comment Extension Sought

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AdvaMed asks FDA for 60 additional days for comments on the agency report on strengthening the national system for medical device ...

Alere Warned About QS Violations

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FDAs Los Angeles District Office warns Alere about Quality System Regulation violations in its manufacturing of Triage cardiac mar...

FDA Releases List of NECC Customers

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FDA posts lists of 1,279 New England Compounding Center customers that were shipped injectable medications on or after 5/21.

FDA, MediciNova Hold Bedoradrine Phase 2 Meeting

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FDA and MediciNova hold an end-of-Phase 2 meeting on the companys bedoradrine (MN-221) for treating asthma and COPD acute exacerba...

Pre-submission Medical Device Meeting Guidance Praised

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Stakeholders say they support FDAs efforts in a draft guidance on medical device pre-submission meetings.

Inspectors Find Quality Problems at Global Medical

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FDAs Kansas City District Office warns Global Medical Products about Quality System Regulation violations in its production of res...