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However, they will not automatically move into Category 1, where the agency has stated it would generally not take action against compounders
doi: 10.1016/j.taap.2004.08.012
The majority of studies utilize rodents, which exhibit different neurobiological responses to ethanol compared to humans
The FDA guidance published in 1993 left the decision of including women of childbearing potential up to the researchers, IRBs, and women enrolling in the trial.34 In 1998, the FDA provided an updated guidance on the topic mandating sponsors to understand sex differences in PK, safety, and pharmacological response
