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As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.
1 Europe, however, is well placed to become a leader in driving the clinical translation of medications that display significant promise in laboratory-based studies. 3 With established drugdevelopment pathways, we are accustomed to a rigid structure of translation from bench to bedside. Expert Review of ClinicalPharmacology.
Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. ClinicalPharmacology & Therapeutics , 97(3) , 263–273.
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