BIO Comments on REMS Assessment: Planning and Reporting
BIO submitted comments to the Food and Drug Administration (FDA) on the draft guidance, REMS Assessment: Planning and Reporting.
BIO says the guidance offers clear, practical information to sponsors and other stakeholders involved in the design and effectiveness evaluation of REMS programs. It provides instrumental recommendations, particularly on how the REMS program goals, objectives, and design may impact the selection of metrics and data sources, which will be used to assess whether the program is meeting its risk mitigation goals.
BIO requests clarifications, particularly on how existing REMS would be grandfathered and evaluation of the burden on healthcare system and patient access. In addition, BIO would welcome the opportunity to partner with the FDA to define improved metrics to evaluate safety-related health outcomes.