6/5/2013 5:15:00 PM
Drugmakers need to shift from phased, single-drug clinical trials toward a new paradigm of collaborative assessments of multiple drugs based on biomarkers, CDER Director Janet Woodcock said May 21, using the ongoing breast cancer trial I-Spy 2 as an illustrative example.
6/5/2013 5:15:00 PM
The European Parliament’s public health committee May 29 adopted draft rules calling for simplified clinical trial reporting procedures and enhanced authority for European Commission inspections.
6/5/2013 5:15:00 PM
While FDA financial disclosure rules require investigators to provide sponsors with their financial information, at the end of the day “the buck stops” with the sponsor, a legal expert says.
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