FDA opens up access to experimental meds
This is a discussion on FDA opens up access to experimental meds within the Biotechnology News forum, part of the Industry News and Updates category; Seriously ill patients with no remaining therapeutic options will be given access to experimental meds under new rules released by ...
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08-13-2009, 12:05 PM
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FDA opens up access to experimental meds
Seriously ill patients with no remaining therapeutic options will be given access to experimental meds under new rules released by the FDA. In the face of developers' worries that open access to experimental drugs could scuttle the clinical trial process, giving patients less reason to volunteer for a study, the agency has required that the developer and the FDA have to jointly agree on preclinical use of a drug. Patients can be charged for the cost of manufacturing and administering the drug. Report
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