Intelligence · Live dashboard

What FDA is focusing on right now

Aggregate signal across the most recent 100 updates indexed by simplyFDA.

Total updates
110
This week
39
Critical signals
1
Sample size
100
By category
  • Devices
    29
  • Biologics
    20
  • Food
    20
  • Drugs
    18
  • Other
    11
  • Tobacco
    1
  • Cosmetics
    1
By type
  • Recall
    40
  • Safety Alert
    19
  • Update
    18
  • Press Release
    12
  • Warning Letter
    6
  • Approval
    4
  • Guidance
    1
By importance
  • medium
    62
  • high
    30
  • low
    7
  • critical
    1
Most-mentioned companies
  • Grace and Fire USA Inc.
    2
  • Hillestad Pharmaceuticals USA
    1
  • Glenmark Pharmaceuticals Inc., USA
    1
  • FDA Center for Biologics Evaluation and Research (CBER)
    1
  • N/A - Source provides limited detail
    1
  • Drug manufacturers
    1
  • Device manufacturers
    1
  • Biologics manufacturers
    1
  • The a2 Milk Company (a2MC)
    1
  • Sponsors utilizing AI/ML tools in drug development
    1
  • Source does not list specific companies
    1
  • Revolution Medicines
    1
Most-affected departments
  • Quality Assurance
    89
  • Regulatory Affairs
    85
  • Clinical Operations
    25
  • Compliance
    15
  • Medical Affairs
    4
  • Labeling and Packaging Designers
    1
  • Labeling and Advertising
    1
  • Clinical Operations/Research
    1
  • Regulatory Affairs Intelligence
    1
  • Digital Transformation
    1
  • Health Informatics
    1
  • Compliance Data Management
    1
Coverage

simplyFDA aggregates openFDA (drug labels, device events, drug/device/food enforcement) with FDA RSS feeds (Press, MedWatch, Recalls). Each item is normalized, deduplicated, and analyzed by a regulatory-trained AI pipeline that produces 4-section structured intelligence and importance scoring.

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