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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. Cross-Sectoral Health Threats
          3. 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. IMEDS
          3. Post Market Research
          4. RAISE
          5. Real World Data
          6. Regulatory Science Accelerator
        3. Substance Use Disorders
  • News and Events
      1. Innovations in Regulatory Science & Policy Awards
      2. 2025 Annual Public Meeting
      3. Events
      4. News
      5. Publications
  • Expanded Access eRequest

A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema

  • Read more about A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema

Expanded Access Protocol Using 131I-MIBG

  • Read more about Expanded Access Protocol Using 131I-MIBG

Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants

  • Read more about Expanded Access to T-cell Depleted Haplo-Identical Stem Cells for Patients Receiving Haplo-Identical and Unrelated Cord Blood Transplants

Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221

  • Read more about Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221

Master Rollover Protocol for Continued Safety Assessment of Study Drug

  • Read more about Master Rollover Protocol for Continued Safety Assessment of Study Drug

CTL019 Out of Specification MAP for ALL or DLBCL Patients

  • Read more about CTL019 Out of Specification MAP for ALL or DLBCL Patients

Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia

  • Read more about Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia

Individual Patient Compassionate Use of Fedratinib

  • Read more about Individual Patient Compassionate Use of Fedratinib

Expanded Access of Vigil in Solid Tumors

  • Read more about Expanded Access of Vigil in Solid Tumors

Intermediate Expanded Access Protocol CNMAu8.EAP03

  • Read more about Intermediate Expanded Access Protocol CNMAu8.EAP03

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