BIO Comments on REMS Assessment: Planning and Reporting
April 2, 2019
BIO submitted comments to the Food and Drug Administration (FDA) on the draft guidance, REMS Assessment: Planning and Reporting.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.
Download Full Comments Below
FINAL BIO Letter REMS Assessment Planning And Reporting
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
BIO submitted comments to the Food and Drug Administration (FDA) on the draft guidance, REMS Assessment: Planning and Reporting.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.