• Regulatory NewsRegulatory News

    FDA official pushes for cloud-based regulatory assessments

    A top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving towards this platform through ongoing internal and international harmonization initiatives at a 30 November symposium on drug master files (DMFs) and structured data submissions.   Lawrence Yu, director of the Office of New Drug Products (ONDP) in the Pharmaceutical Quality (OPQ) at ...
  • Regulatory NewsRegulatory News

    FDA taking incremental approach to launching KASA reviews

    The US Food and Drug Administration (FDA) is taking a “step-wise” approach to implementing its Knowledge-Aided Assessment and Structured Application (KASA) drug review program. The review program has already launched for abbreviated new drug applications (ANDAs) for solid oral dosage forms and will eventually be rolled out for new drug applications (NDAs) and ANDA liquid dosage forms in FY 2023. KASA will be phased in for investigational new drug applications (INDs) and po...
  • Regulatory NewsRegulatory News

    FDA Explains Plans for New Pharmaceutical Quality Assessment System

    As part of its work to improve and modernize the quality assessment of drug applications, the US Food and Drug Administration (FDA) is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics . The authors describe KASA as a new s...