Regulators, FDA CDER Publish Draft Guidance for industry on Risk Evaluation and Mitigation Strategies (REMS)
This document provides guidance to industry on:
- The format and content of a proposed risk evaluation and mitigation strategy (REMS), including REMS supporting documentation;
- The content of assessments and proposed modifications of approved REMS;
- What identifiers to use on REMS documents; and
- How to communicate with FDA about a REMS.
The information on the content of a proposed REMS submission (section III of this document) also applies to proposed REMS that are voluntarily submitted by applicants or holders of approved applications (see section II.A of this document).
This guidance will address REMS elements and provisions that are broadly applicable to proposed REMS and to assessments and modifications of approved REMS. Other provisions, such as those that pertain only to abbreviated new drug applications (ANDAs), or expanded information about REMS assessments and proposed modifications, will not be fully addressed, but will be the subject of future guidance.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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