The 10-page guidance explains how the Food and Drug Administration Amendments Act  requires FDA to consider the following six factors in deciding whether to require a REMS: 

  • “The seriousness of any known or potential adverse events that may be related to the drug and the background incidence of such events in the population likely to use the drug;
  • The expected benefit of the drug with respect to the disease or condition;
  • The seriousness of the disease or condition that is to be treated with the drug;
  • Whether the drug is a new molecular entity;
  • The expected or actual duration of treatment with the drug; and
  • The estimated size of the population likely to use the drug.”


REMS: FDA’s Applcation of Statutory Factors in Determining When a REMS Is Necessary: Guidance for Industry