FDA Flags Missing Trial Results - Takeaway - MDSpire
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FDA Flags Missing Trial Results

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  • 1

    FDA sent reminders to 2,200 companies about reporting trial results.

  • 2

    29.6% of required studies had no results posted.

  • 3

    Excludes phase 1 trials and device feasibility studies.

  • 4

    Results must be submitted within 1 year of completion.

  • 5

    Gaps in reporting can lead to publication bias.

  • 6

    Correspondence aims for voluntary compliance before enforcement.

  • 7

    Importance of transparency emphasized by FDA officials.

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