sábado, 11 de noviembre de 2017

REMS Integration Initiative

In 2011, the Food and Drug Administration (FDA) launched the REMS Integration Initiative with the goal of standardizing Risk Evaluation and Mitigation Strategy (REMS) programs and better integrating them into the healthcare delivery system. The REMS Integration Initiative was built on stakeholder feedback, and leveraged activities such as public meetings, workshops, listening sessions and a pilot program to ensure comprehensive stakeholder representation. We are very grateful to all those who contributed their time and perspectives to this project. FDA has issued various reports and guidances over the course of this initiative describing what we heard and how we responded. A comprehensive list of work completed can be found on our REMS Integration Initiative website
However, there are a few recent REMS-related publications that we would like to highlight for stakeholders, including the:
The REMS Integration Initiative ended on September 30th 2017 and is a major milestone in FDA’s drive to improve REMS. However, the end of the REMS Integration Initiative does not mean the end of FDA’s efforts to improve REMS. Feedback is welcomed. Stakeholders interested in providing feedback on the new REMS document template or the use of the DMF should provide comments to the related dockets. In addition, the REMS Platform Standards Initiative is just one example of a new project to continue improving REMS and is a key part of FDA’s mission to make safe and effective therapies available. The REMS Platform comment period will be open indefinitely.  

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