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Home
  • About
      1. Board of Directors
      2. Our Staff
      3. Annual Reports
      4. Policies
      5. Fellowship
      6. Careers
  • Projects
      1. Column 1
        1. Animal Health & Veterinary Medicine
          1. Antimicrobial Use in Food Animals
          2. Industry SWOT Analysis
        2. Expanded Access
          1. E-request App
          2. Navigator
          3. Resources for COVID-19
        3. FDA Patient Listening Sessions
        4. Food & Nutrition
          1. About
          2. Food Traceability
          3. Healthy Rule Roundtables
          4. Nutrition Facts Label
          5. Produce Safety Stakeholder Dialogue
          6. Retail Dietitian Toolkit
      2. Column 2
        1. Improving Access to FDA Information
          1. Understanding FDA & FDA-Regulated Products
          2. Improving Access to Publicly Available FDA Information
        2. Research
          1. About
          2. Cross-Sectoral Health Threats
          3. IMEDS
          4. Post Market Research
          5. RAISE
          6. Real World Data
          7. Regulatory Science Accelerator
        3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. 2024 Annual Public Meeting
      3. Events
      4. News
      5. Publications
  • Expanded Access eRequest

The Health Care Blog Shares Uses for Navigator

This post points out that the Navigator will expand from an oncology focus to other therapeutic areas in the future, and walks through a hypothetical Zika case where clear expanded access information would be critical.

Coverage
  • Read more about The Health Care Blog Shares Uses for Navigator

Pharmaceutical Commerce links Gottlieb to Navigator's aims

This magazine article says the Navigator streamlines information-gathering and links the launch to FDA Commissioner Scott Gottlieb's statements that the expanded access process should be less expensive and time-consuming.

Coverage
  • Read more about Pharmaceutical Commerce links Gottlieb to Navigator's aims

Biotech-Now Urges Companies to Use Navigator Directory

This blog from the Biotechnology Innovation Organization reminds companies they can comply with the 21st Century Cures Act’s requirements to make their expanded access policy publicly available by listing it on the Expanded Access Navigator's Company Directory.

Coverage
  • Read more about Biotech-Now Urges Companies to Use Navigator Directory

Infodocket Credits Team Effort for Navigator

Quoting the FDA Voice Blog, this online post mentions the Navigator's public-private partners who help guide patients and physicians through the expanded access process.

Coverage
  • Read more about Infodocket Credits Team Effort for Navigator

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© Reagan-Udall Foundation for the FDA
© Reagan-Udall Foundation for the FDA