FDA Modernizes Drug Quality Assessment with KASA

May 6, 2024
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The FDA is transforming drug quality assessments with the new Knowledge-aided Assessment & Structured Application (KASA) system.

This innovative platform captures knowledge throughout a product’s lifecycle, utilizes algorithms for risk assessment and supports computer-aided analysis, promoting efficiency and clarity in the FDA drug approval process.

Key Benefits of KASA:

  • Enhances knowledge management and decision-making.
  • Streamlines risk assessment and control for products and manufacturing facilities.
  • Encourages the use of digital technology to improve regulatory submissions.

 

ASPHALION CAN HELP WITH:

  • Compilation of product quality data in a structured format.
  • Support with M4Q guidelines and recommendations when preparing the quality section of the dossier.
  • Support with electronic data standards.
  • Ensuring
  • Updating change management

 

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