relevance of the data. It should also include a characterization of the uncertainty around the estimates of the benefits and risks.

3. Regulatory Actions and Rationale

This section should have a clear statement of the regulatory decision, and the rationale for that decision, including not only the final output of the benefit–risk assessment process but a description of any other factors that affected the decision, such as ethical issues, timeframe issues, the lack of an available treatment for a disease, or the risk posed by a drug in a specific population. It should also include a description of any VOI analysis, decision conferencing, or multiple-criteria decision analysis that was conducted If there are any regulatory requirements that are meant to highlight or mitigate a drug’s risks, such as labeling changes, boxed warnings, or a REMS, those requirements should be described in this section. This section should also include a description of any postmarketing surveillance, studies, or trial requirements or commitments.

a. Regulatory Decision

This section should include a statement of the regulatory decision, such as approval of the drug or the requirement for a postmarketing requirement.

b. Rationale

This section should discuss the rationale for the regulatory decision, including a description of any factors other than the benefit and risk assessment that might have affected the decision, such as ethical issues, patient perspectives, timeframe issues, the lack of an available treatment for a disease, and the risk posed by the drug in a specific population.

c. Concomitant Actions

This section should discuss any actions needed to highlight or mitigate a drug’s risks, including labeling, boxed warning, REMS, and postmarketing study requirements. It includes a discussion of the rationale for requiring these changes, and any remaining public health questions that need to be answered by postmarketing requirements.

4. Schedule of Future Reviews

This section should include a schedule of future evaluations of the benefit–risk profile, taking into account when additional information on the benefits or



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