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Comment & Response
September 19, 2017

Characteristics of Novel Therapeutics and Postmarket Safety Events—Reply

Author Affiliations
  • 1Brigham and Women’s Hospital, Boston, Massachusetts
  • 2Mayo Clinic, Rochester, Minnesota
  • 3Yale University School of Medicine, New Haven, Connecticut
JAMA. 2017;318(11):1067-1068. doi:10.1001/jama.2017.11517

In Reply Dr Tanimoto and colleagues suggest that 3 additional characteristics of novel therapeutics or features of their regulatory approval should be considered when examining potential predictors of postmarket safety events after approval by the FDA: expected length of treatment, first approval by a peer regulator, such as the EMA, and total number of patients participating in the manufacturer’s pivotal trial program. We appreciate these suggestions and in response have examined whether postmarket safety event risk was associated with either expected length of treatment or relative number of patients participating in premarket clinical studies. However, we did not examine first approval by a peer regulator because new drug application submission occurs more or less simultaneously to the FDA and EMA, with approval within a few months.1