Track-And-Trace Regs Need Serial Number Randomization, Consultant Says
Though not required by law, process offers “a little bit of a brand protection.”
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FDA Counterfeit Screening Tool Gets Field Test In Ghana; Corning Prepares Device For Mass Production
FDA currently employs the CD3 in its laboratories and at a number of international mail facilities and other points of entry to the U.S. to screen cosmetics, foods, medical devices and cigarettes, as well as drugs.
Track And Trace: Substandard System Is Not Better Than Nothing, FDA Says
CDER Director Janet Woodcock says an industry coalition’s proposal would not meet FDA’s drug tracking needs and is not worth the cost of implementing, even though industry says FDA’s preference is cost-prohibitive.
US FDA Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval
Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.