FDA Reviewers Share CMC, GMP Challenges In Last Year's Rush To Approve New Therapies
Inundated with high-priority applications last year, US FDA's CMC reviewers struggled with seemingly thrown-together review packages, moving-target manufacturing processes and not-on-the-same-page contract manufacturers.
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Median review times for US agency's drug center were 10 months from 2011 to 2013, and 11 months from 2015 to 2016.
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