Professor Sam Salek calls for a “universal framework” for new drugs

The review of medicines by regulatory agencies is largely based on the submission of clinical data collected from clinical trials phases I to IV….For example, parameters like blood pressure, cholesterol levels or microbial eradication may not actually translate to reduced cardiovascular events or a faster recovery from an infection….The lack of such a system could in turn result in inconsistency in approval of new medicines, making them available to patients in some parts of the worlds and denying them in others.

http://www.epmmagazine.com/opinion/solving-the-global-benefit-risk-assessment-dilemma/

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