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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ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.
Requests for meetings with FDA staff about products in development should include pertinent details about pediatric study plans, human factors engineering plans and combination product information; new guidance documents on formal meetings under PDUFA VI and communications with IND sponsors operationalize user fee program commitments and will promote earlier, more thorough engagement, agency says.
Median review times for US agency's drug center were 10 months from 2011 to 2013, and 11 months from 2015 to 2016.