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Comment & Response
December 2017

Drug Trials Snapshots and Sexless Drug Labels—Reply

Author Affiliations
  • 1Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. 2017;177(12):1868-1869. doi:10.1001/jamainternmed.2017.5646

In Reply We posited that the difference between the number of sex-specific statements made in the Drug Trials Snapshots vs the drug label may be owing to the legal requirements imposed on the prescribing information, for which sex demographic labeling is not a required subsection.1 Our premise was that the prescription drug label and Drug Trials Snapshots fulfill different purposes, which may lead to differences in the number of sex-specific statements.