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Robotic Surgery Complications May be Under-reported: Study

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A Johns Hopkins study says that the number of adverse events associated with robotic surgery may be under-reported.

Info on Submitting Info to CVM with e-Submission Gateway

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Federal Register Notice: FDA submits a proposed collection of information on submitting information in electronic format to CVM us...

Guidance on Non-Clinical Testing for Intravascular Stents

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Federal Register Notice: FDA releases a draft guidance: Select Updates for Non-Clinical Engineering Tests and Recommended Labeling...

FDA Nixes Expanded Indication on Otsukas Tolvaptan

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FDA sends Otsuka a complete response letter on its NDA for tolvaptan for an expanded indication in treating adult patients with ra...

FDA Gives Cepheid TB Test Moderate Complexity Designation

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FDA categorizes Cepheids Xpert MTB/RIF test as moderate complexity under the Clinical Laboratory Improvement Amendments (CLIA).

FDA Makes Priority Reviews More Restrictive: PhRMA

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PhRMA says FDA has made qualifying criteria for drug and biologic makers to obtain a priority review designation more restrictive.

FDA Clears Royal Phillips Ultrasound

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FDA clears a Royal Philips Electronics 510(k) for the EPIQ ultrasound system.

FDA Needs Modern Regulatory Approach for Innovation: White Paper

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An Epstein Becker & Green white paper says FDA should update its regulatory system to accommodate the new reality of e-health.

Expedited Review Programs Guidance Well-crafted: Merck

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Merck says an FDA draft guidance on expedited drug and biologics programs for serious conditions will be very helpful to sponsors ...

J&J Adding Warning to Tylenol Bottle Caps

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Johnson & Johnson says it will add warnings to caps of Tylenol bottles stressing that the OTC product contains acetaminophen.