Drugs

2 REMS Assessment MAPPs

CDER has issued two Manuals of Policies and Procedures (MAPP) dealing with aspects of REMS (Risk Evaluation and Mitigation Strategy) assessment. The first MAPP, Review of Proposed Methodological Approaches to Assess a Risk Evaluation and Mitigation Strategy, says REMS assessments may be required when applicants submit a supplemental application for a new indication for use, when required by the REMS, or whenever FDA determines that an assessment is needed to evaluate whether the proposed REMS should be modified to ensure the benefits of the drug outweigh the risks, or to minimize the burden on the healthcare delivery system of complying with the REMS.

The MAPP says a variety of methodological approaches may be used to support an assessment of a REMS program to evaluate knowledge, safe use behaviors, patient outcomes, and compliance with REMS requirements.

The second MAPP, Review of Risk Evaluation and Mitigation Strategy Assessment Reports, describes how CDER will review the REMS assessment reports that are submitted to the agency as required by law. It also describes how CDER will notify applicants when REMS assessment reports are not submitted on time, submitted with missing required information, or the submitted information requires additional review time to decide whether the REMS is meeting its goals.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome