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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

INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old

  • Read more about INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old

Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID

  • Read more about Neurobiological Underpinnings of Neuropsychological Consequences in Long COVID

Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19).

  • Read more about Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19).

Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2

  • Read more about Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2

Accelerated approval will be 'the norm' for gene therapies, FDA's Peter Marks says - Endpoints

The FDA will increasingly use accelerated approval for gene therapies aimed at rare conditions, according to Peter Marks, the FDA’s top official overseeing cell and gene therapies, the clearest signal yet of how widely the agency will deploy its expedited pathway.

Read more

Coverage
  • Read more about Accelerated approval will be 'the norm' for gene therapies, FDA's Peter Marks says - Endpoints

Post-COVID-19 Chronic Fatigue Syndrome

  • Read more about Post-COVID-19 Chronic Fatigue Syndrome

COVID-19 Booster Study in Healthy Adults in Australia

  • Read more about COVID-19 Booster Study in Healthy Adults in Australia

How biomarkers can support regulatory rare disease pathways - BioNews

On February 21, the Biotechnology Innovation Organization’s (BIO) soon-to-be CEO, John F. Crowley, joined an event about biomarkers and rare disease regulatory pathways, hosted by the Reagan-Udall Foundation for the Food and Drug Administration in Washington, D.C.

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Coverage
  • Read more about How biomarkers can support regulatory rare disease pathways - BioNews

Orano Med

By jpalfreyman on Fri, 02/23/2024 - 09:54
  • Read more about Orano Med

RadioMedix

By jpalfreyman on Fri, 02/23/2024 - 09:51
  • Read more about RadioMedix

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