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Category Archives: Regulatory Expertise

Breaking News – April 18, 2012

Lilly wins FDA approval for Alzheimer’s imaging agent

New Lilly drug has small sales potential

Is the FDA killing innovation?

Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

FDA approves medical-image software for Apple mobile devices

FDA approves first mobile diagnostic viewing app

FDA approves F-18 NaF for PET bone scans

AVEO Pharmaceuticals starts exploratory biomarker trial enrollment

FDA unveils new plan of action for 510(k) process

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