The St. George’s Respiratory Questionnaire Appendix to the Food and Drug Administration Draft Guidance on COPD

Why a Small Step Forward Is So Important
      Understanding of biology in general and of human disease specifically is advancing at an ever-accelerating rate. Paradoxically, this explosion of new knowledge is increasingly accompanied by an ever-slowing rate in the development of new medicines.

      Food and Drug Administration. Innovation/stagnation: challenge and opportunity on the critical path to new medicinal products. 2004. http://www.fda.gov/downloads/scienceresearch/specialtopics/criticalpathinitiative/criticalpathopportunitiesreports/ucm113411.pdf. Accessed February 1, 2017.

      There are some exceptions, notably in oncology, where novel biologically based treatments that rely on advanced diagnostic information are leading to ever more durable remissions. Part of the challenge for many diseases, however, is that conventional tools for clinical assessment, many of which date to the 19th century, are inadequate to assess new treatments based on modern biology.
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      References

      1. Food and Drug Administration. Innovation/stagnation: challenge and opportunity on the critical path to new medicinal products. 2004. http://www.fda.gov/downloads/scienceresearch/specialtopics/criticalpathinitiative/criticalpathopportunitiesreports/ucm113411.pdf. Accessed February 1, 2017.

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