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.

In the case of drug-tracking requirements, FDA does not feel something is better than nothing.

Lawmakers still have not come to an agreement on a national drug-tracking system standard to allow companies and the agency...

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