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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-separate-marketing-applications-and-clinical-data-purposes-assessing-user-fees
This guidance describes FDA’s current thinking on what will be considered a separate marketing application and what will constitute clinical data for purposes of the user fee provisions of the ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4189455/
In summary, unlike observational epidemiological studies, the current meta-analysis of RCTs found that there is no clinical evidence to support the efficacy of vitamin and antioxidant supplements in the prevention of esophageal cancer.Cited by: 4
https://www.thebody.com/article/cm-4-herbal-supplement-clinical-data-support
Dec 01, 2004 · CM4 is not a new product -- ATI has been carrying it for several years -- but clinical and laboratory research is now available that documents the efficacy of this herbal supplement both as an ...
https://www.documentcloud.org/documents/3162785.html
Source document contributed to DocumentCloud by Vitor Baptista (Open Knowledge Foundation).
https://www.pharmacytimes.com/news/three-year-data-support-efficacy-of-biosimilar-ontruzant-in-breast-cancer
Three-year follow-up data demonstrated comparable overall survival (OS) and cardiac safety between biosimilar trastuzumab (Ontruzant, Samsung Bioepis) and the reference product (Herceptin, Genentech), according to a recent phase 3 study. The data were presented at the 16 th St. Gallen International Breast Cancer Conference 2019 in Vienna, Austria.
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