US FDA Eyes New Investigational Drug Label Requirements That Bring International Harmonization
To help reduce medication errors that can harm patients and compromise research results, FDA – pushed by clinical trial sites – looks to exert more control of the labels of investigational drug products.
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US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.
FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.
CDER Director Cavazzoni also wants to loosen conflict of interest rules and improve technology for remote meetings. Given FDA’s approval of Aduhelm, her comments, made in a prerecorded interview for the BIO Digital annual meeting, may raise some eyebrows. Industry is also working on recommendations for the agency on the topic.