Track and Trace Standards Coming Shortly, FDA Says
Standards were required in FDAAA; industry asked for them in part to avoid conflicts with California pedigree law that will be implemented in 2015.
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FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.
Legislative language would consider a drug adulterated if it does not have the necessary quality management systems in place as required in current Good Manufacturing Practices.
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.