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- Title
Evaluation of Publicly Available Information on Sex-Related Differences in the Efficacy and Safety of Newly Approved Medications.
- Authors
Hong, Kyungwan; Tanveer, Sarah; Hassan, Hazem E.; Doshi, Peter
- Abstract
Efficacy data by sex was discussed in 31 of 39 (79.5%) FDA clinical reviews, 39 (100%) FDA Drug Trials Snapshots, 8 (20.5%) FDA drug labels, and 12 (19.4%) trial publications (Table 2). Funding: This project was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling $10,000 with 100% funded by FDA/HHS. KH was supported in 2020 by the FDA of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946 totaling US$5,000 with 100% funded by FDA/HHS.
- Subjects
DRUGS; CLINICAL drug trials; PARKINSON'S disease; SCIENTIFIC literature; CLINICAL prediction rules
- Publication
JGIM: Journal of General Internal Medicine, 2022, Vol 37, Issue 11, p2894
- ISSN
0884-8734
- Publication type
Article
- DOI
10.1007/s11606-022-07421-8