The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) performs an essential public health task by ensuring that safe and effective quality drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.

 

FDA CDER faces various challenges including: a large volume of regulatory drug applications, shorter assessment timelines, inconsistencies in regulatory actions due to subjective risk assessment and control, and unstructured text narratives that often includes exhaustive documentation of information already provided in the application.

To address some of these challenges relating to drug safety and quality, the FDA implemented the Knowledge-aided Assessment and Structured Application (KASA) application. KASA is a critical initiative to CDER—and more broadly the FDA—as one of the key initiatives to help modernize the FDA’s quality assessment and oversight process.  KASA is a structured review system for assessors to consistently perform Pharmaceutical Quality Regulatory Review for generic oral drug quality. The system increases productivity and introduces efficiencies in the review process to ensure the quality of drugs to the public. 

 

The Office of Pharmaceutical Quality (OPQ) KASA product team worked closely with the Office of Business Informatics (OBI) to implement the KASA application. The goals were to:

1. Capture and manage knowledge during the lifecycle of a drug product by establishing rules and algorithms to facilitate risk identification, mitigation, and communication for the drug product, manufacturing process, and facilities.

2. Perform computer-aided analyses of applications for a comparison of regulatory standards and quality risk across the repository of approved drug products and facilities.

3. provide a structured assessment that radically eliminates text-based narratives and summarization of information from the applications.
    

Moving KASA into CDER NEXUS platform marks significant progress in realizing a streamlined, efficient, and consistent risk-assessment process that also offers control communication, and the full potential of historical and current knowledge management.

 

The successful rollout of KASA was made possible through an integrated collaboration between CDER and Office of Digital Transformation (ODT). The result is the agency’s first FISMA High environment that hosts the KASA application that houses OPQ assessment and information submitted by the sponsors.

The benefits of KASA include:

• Improvements in consistency, transparency, communication, and objectivity of regulatory actions

• Enabling assessors to automatically retrieve historical data and facility information in order to better inform regulatory evaluation and decision-making process

• Facilitating assessment of risk to reduce subjectivity and time-consuming tasks

• Allowing the detection of outliers in the control strategy and risk attributes in order to improve quality and efficiency

Office of Pharmaceutical Quality:

ANDRE RAW

Structured Review Product Owner

 

LARISA WU

Drug Substance Implementation Lead

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STEVEN KOZLOWSKI

KASA Steering Committee Lead

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LAWRENCE YU

KASA Steering Committee Lead

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STELIOS TSINONTIDES

KASA Steering Committee Lead

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SUSAN ROSENCRANCE

KASA Steering Committee Lead

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PETER CAPELLA

Drug Product Implementation Lead

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CHARLES ROBERTSON

Application SME

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RAKHI SHAH

Manufacturing Implementation Lead

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BHAGWANT REGE

Biopharmaceutics Implementation Lead

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DANIEL OBRZUT

Manufacturing SME

ZHOUXI (JOSIE) WANG

Manufacturing SME

JINGBO XIAO

Manufacturing SME

PARESMA PATEL

Drug Substance SME

DAVID GREEN

Drug Substance SME

ERIN SKODA

Drug Substance SME

MICAEL GUILLOT

Drug Product SME

RYAN NGUYEN

Drug Product SME 

BROCK ROUGHTON

Drug Product SME

KIMBERLY RAINES

Biopharmaceutics SME

ANITHA GOVADA

Biopharmaceutics SME

XIANG (SHANE) YU

Application SME

RONGZUO XU

Application SME

Office of Strategic Programs:

SOPHIA YU

Business Informatics Lead

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SUNITHA MATHEWS

Business Informatics Lead

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ETHAN CHEN

Business Informatics Lead

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RANJIT THOMAS

Project Management Officer - Budget

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ARCHANA NARAYANASWAMY

Product Manager

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SARA WU

Technical Delivery Manager

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SORIN NASTEA

Enterprise Architect

 

ROGER LAM

Budget Support Lead

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SUSANNE LENK

Business Informatics SME

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STEPHANIE DAI

Business Informatics SME

 

ROHAN CHATTERJEE

Data Analyst and Data Delivery

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MICHELLE GARRETT

End to End Test SME

LAURA LOURENCO

UI/UX SME

SARMA LOLLA

Data Delivery SME

SABUJIMA  DAS

Technical SME

JIANKUN HUANG

 Implementation Technical SME

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MAHMOUD ABUELROOS

Budget Support

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ASHWIN SUTHRAVE

Lead Architect

HUMAA KAZMI

Functional SME

BHAVYADEEP SUHALKA

 Business Architect

CHARU SAKLECHA

COTS Specialist

VENKATA KUKATLA

COTS Specialist

KYLE BERGER

COTS Specialist 

PRAVEEN DADIVELA

COTS Specialist

NEIL PARMAR

COTS Specialist 

ANAGA LAXMI NIMMAGDDA

Sr. Test Engineer

XENIYA FESENKO

Sr. Test Engineer

INGRID NKENLIFACK-MAAGUE

Business Process Analyst

DANIEL HOROWITZ

Business Process Analyst

 

Global Substance Registration System:
TYLER PERYEA

Drug Substance Technical SME

FRANK SWITZER

Drug Substance Registration Application SME

MARLENE KIM

Drug Substance Registration Application SME