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Barbara Kram, Editor | April 02, 2007
The MHRA, the British regulatory agency, has published "Making Regulatory Decisions about Medicines and Medical Devices."
This document sets out:
* the main regulatory decisions that are made about medicines and medical devices;
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* the principles that inform these decisions;
* the questions that are considered to ensure that the decisions are reasonable, and
* who makes decisions about medicines and medical devices - which includes bodies other than MHRA.
MHRA drafted the document after consultation with a range of external stakeholders, including healthcare professionals, bodies which represent patients and the public, and the pharmaceutical and medical devices industries.
The agency invites further comments and will consider all comments and expect to publish a revised version in the summer of 2007.
To read the document and comment, go to:
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030698&ssTargetNodeId=387
