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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

Cetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With a PD-L1 Combined Positive Score (CPS)≥1≤19.

  • Read more about Cetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With a PD-L1 Combined Positive Score (CPS)≥1≤19.

Evaluation of MicroRNAs and Vitamin B12 Expression in Subjects with Neurologic Symptoms of Depression, Anxiety and Fatigue in Long COVID-19

  • Read more about Evaluation of MicroRNAs and Vitamin B12 Expression in Subjects with Neurologic Symptoms of Depression, Anxiety and Fatigue in Long COVID-19

A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age

  • Read more about A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to

Post COVID-19 Syndrome Treatment With Variable Pulse Transcranial Magnetic Stimulation

  • Read more about Post COVID-19 Syndrome Treatment With Variable Pulse Transcranial Magnetic Stimulation

Relative Bioavailability Study of CX2101A for the Treatment of COVID-19

  • Read more about Relative Bioavailability Study of CX2101A for the Treatment of COVID-19

Enhancing Breastfeeding Self-Efficacy in Filipino Mothers: Assessing the Impact of the LactApp m-Health Tool

  • Read more about Enhancing Breastfeeding Self-Efficacy in Filipino Mothers: Assessing the Impact of the LactApp m-Health Tool

A Single-center, Interventional Diagnostic Study With Minimal Risks and Constraints, Aimed at Longitudinally Evaluating Serum Antibody Levels in Patients With COVID-19 According to the Severity of Their Symptoms.

  • Read more about A Single-center, Interventional Diagnostic Study With Minimal Risks and Constraints, Aimed at Longitudinally Evaluating Serum Antibody Levels in Patients With COVID-19 According to the Severity of Their Symptoms.

A Study of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects

  • Read more about A Study of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects

BioCentury: The next rare disease roadblock: American innovation moving ex-U.S.

Members of the consortium have had an ongoing dialogue with the hub, Critical Path Institute, the Reagan-Udall Foundation, and AMP ALS since mid-2024.
Coverage
  • Read more about BioCentury: The next rare disease roadblock: American innovation moving ex-U.S.

Primary Mitochondrial Diseases

  • Read more about Primary Mitochondrial Diseases
The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), hosted a virtual, public workshop to explore opportunities to optimize therapeutic development to address primary mitochondrial diseases.

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