Rebecca Hubbard

2 weeks ago | bmjoncology.bmj.com | Martin Kurian |William Ferrell |Ernesto Pérez |Rebecca Hubbard

For drug indications receiving accelerated approval (AA), the Food and Drug Administration (FDA) imposes postmarketing requirements (PMRs). The FDA and sponsors negotiate parameters for PMR studies, including design features and submission timelines, which are formalised as PMR statements. PMR studies have been criticised for delay and lack of rigour; the contribution of PMR statements to this problem has not been well studied.