FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications

  • Palak Govani Master of pharmacy
  • Krupa Bahekar
  • Vinit Movaliya
  • Khushboo Vaghela
  • Niranjan Kanki
  • Shrikalp Deshpande
  • Maitreyi Zaveri


This review paper is about FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications (KASA). The aim of USFDA is Timely development, assessment, and approval of safe and effective drugs is pivotal for assuring the American public has access to quality medicines. At present, the new drug and generic quality assessment is performed using a written narrative. To modernize the assessment of drug applications, a KASA system has been initiated. KASA could become a system that captures and manages information about a drug product including risk identification, mitigation and communication, and control strategy. It does this through a structured IT framework that could completely replace the current unstructured text-based, narrative assessment.

Keywords: Knowledge-aided assessment & structured applications (KASA), USFDA, Office of Pharmaceutical Quality (OPQ), failure mode, effects and criticality analysis (FMECA)


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How to Cite
Govani, P., K. Bahekar, V. Movaliya, K. Vaghela, N. Kanki, S. Deshpande, and M. Zaveri. “FDA’s New Pharmaceutical Quality Initiative: Knowledge-Aided Assessment & Structured Applications”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 4, Dec. 2022, pp. 1-7, doi:10.22270/ijdra.v10i4.523.

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