The steps involved in identifying the 63 ODs for this study.
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https://figshare.com/articles/dataset/The_steps_involved_in_identifying_the_63_ODs_for_this_study_/19636922
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a. The list of 862 ODs approved in the US between 1 January 1983 and 17 April 2020, inclusive, obtained from FDAOD. The information available in FDAOD is provided. b. The list of the 862 ODs’ 552 unique trade names, and their break up into (i) 413 with single approvals, (ii) 139 with multiple approvals and (iii) 40 cases with trade name unavailable. c. Of the 413 single approval trade names, 123 had a single mention in the OB, and 290 either did not have any mention or had multiple mentions in the OB. d. Of the 123 ODs with a single occurrence in the OB, 51 were approved before 1 Jan 2009, and 72 after. e. Of the 72 ODs approved on or after 1 Jan 2009, 63 had publicly available comprehensive FDA documents such as the Medical Review. f. The list of 63 ODs of this study, with their year of marketing approval and the FDA document consulted for this study. g. From 2009–2020, per year (i) the total number of ODs approved, (ii) the number selected for this study, (iii) the percentage selected for this study, (iv) the percentage out of 63 ODs, (v) the cumulative percentage out of 63 ODs, and (vi) the cumulative percentage, out of 63 ODs, in three year segments.
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创建时间:
2022-04-22



