FDA’s Generic Regulatory Science Plan Taking Broad-brush Approach So Far
This article was originally published in The Pink Sheet Daily
Agency lists five topics for industry and stakeholders to focus on during a June 21 meeting on what its fiscal year 2014 priorities should be; among issues for consideration are prioritizing projects based on public health impact and identifying challenges that limit the availability of generic drugs.
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One project will look at tablet size, odor and other characteristics that in the past have been a source of public complaints about generics.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.