The FDA issued draft guidance this week describing a streamlined submission process to determine whether using an in vitro diagnostic in a cancer drug’s clinical trial poses a significant or nonsignificant risk.
The agency wrote that sponsor should use the proposed pathway when possible “to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory review.”
Get the full story at our sister site, Drug Delivery Business News.
The post FDA issues draft guidance for the use of diagnostics in cancer drug trials appeared first on MassDevice.
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