FDA Considering Standardizing International Lab Data for Drug Applications

After years of consideration, the FDA says it may soon require drugmakers to submit lab data using Système International units instead of U.S. conventional units when filing drug applications, making the UK the lone holdout using ounce and fluid ounce measurements. FDA spokesperson Stephen King told DID Wednesday the agency currently does not have a standard method of measurement for data submissions, and that sponsors “can and do” submit data in either measuring standard, which creates inconsistency for reviewers.
Drug Industry Daily