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Feds Want Merck Drug Marketing Info

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Merck says it is cooperating with federal probes into marketing of Integrilin, Avelox, and AzaSite.

FDA Approves Hemacord Cell Therapy

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FDA approves Hemacord, the first hematopoietic progenitor cells-cord cell therapy.

FDA Accepts PMA for Breast Cancer Screening

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FDA accepts for review a U-Systems PMA for a breast cancer screening indication for the somo*v Automated Breast Ultrasound (ABUS) ...

Baxter Recalls 6 Lots of Gammagard

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Baxter recalls six lots of Gammagard Liquid [immune globulin intravenous (human)] 10%, 1g size, due to the potential for metallic ...

FDA Clears Fresenius In-home Dialysis System

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FDA clears a Fresenius Medical Care 510(k) for the 2008K@home, a hemodialysis system for home use.

FDA Clears Ethicon Vessel Sealer

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FDA clears an Ethicon Endo-Surgery 510(k) for the Enseal G2 Curved and Straight Tissue Sealers, intended for use in providing vess...

SOP on Decisions for Changing Premarket Data Rules

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CDRH issues a SOP on decision levels for requests for additional or changed information for premarket submissions.

Guidance on IDEs for Early Feasibility Device Studies

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Federal Register Notice: FDA releases a draft guidance, Investigational Device Exemptions for Early Feasibility Medical Device Cli...

Human Device Investigational Studies Guidances Out

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FDA issues guidances to promote early-stage development of medical devices, including initial trials in humans.

FDA Clears Fresenius Hemodialysis System Enhancements

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FDA clears a Fresenius Medical Care 510(k) for enhanced features including the Clinical Data Exchange for its 2008T hemodialysis d...