• Regulatory NewsRegulatory News

    Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants

    Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Administration (FDA) audit published in the International Journal of Pharmaceuticals .   Authors from the FDA Center for Drug Evaluation and Research (CDER) said these manufacturers had a potential estimated increase in revenue due to the ...
  • Regulatory NewsRegulatory News

    Continuous Manufacturing: FDA Drafts Quality Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic drugs.   The 27-page draft guidance is part of FDA’s effort to encourage the adoption of continuous manufacturing and covers quality considerations for solid oral small molecule drugs and builds on feedback from a public consultation launched in 2017.   According to FDA Commissioner Scott Gottlieb and C...