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Development of a Combination Product Taxonomy and Comparative Human Factors Testing Method for Drug-Device Combination Products Submitted in an ANDA

Award Number: U01FD007360
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2021
PERIOD OF PERFORMANCE END DATE: 07/31/2025

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Development of a Combination Product Taxonomy and Comparative Human Factors Testing Method for Drug-Device Combination Products Submitted in an ANDA - PROJECT SUMMARY This research seeks to improve methods for the identification and analysis of user interface (UI) design differences that may impact substitutability of reference listed drug (RLD) products with generic drug-device combination products (DDCP) that are seeking FDA clearance through the Abbreviated New Drug Application (ANDA) pathway. This research will facilitate regulatory review as well as design and development of generic DDCPs by developing a use-related-risk-based analysis method that can enhance patient access to the medications they need. The proposed aims include: Aim 1. Develop a body of knowledge of key stakeholder perspectives and existing strategies for assessing user interface designs. Aim 2. Develop a visual taxonomy to systematically analyze combination product UI design attributes and facilitate the identification of minor and other design differences as they relate to potential use errors that could cause harm or compromise medical treatment. Aim 3. Develop a method for the comparative analysis of a proposed generic DDCP and its RLD that is based on evaluating UI design differences related to the potential for introducing use errors on critical tasks that could result in harm or compromised medical care. This research will impact human factors methods for assessment of DDCP interchangeability by providing clarity in UI design differences that could lead to potential use errors that could result in harm or compromise medical treatment. The use of a visual taxonomy for classifying UI design attributes of DDCP types is a novel approach that will match current FDA guidance and international standards and support FDA review of human factors data in ANDA submissions. The proposed method will link the use-related risk analysis (URRA) to differences in the UI design attributes specific to DDCPs seeking pre-market clearance through an FDA ANDA pathway. The end goal is a proposed human factors methodology to improve the quality of HF data in ANDA submissions, facilitate more efficient FDA reviews of ANDA submissions, and improve industry acceptance of the proposed methodology.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = -$5,023 )
2026	2023	UNIVERSITY OF DETROIT MERCY	4001 W MCNICHOLS RD	DETROIT	MI	48221	WAYNE	USA	Food and Drug Administration Research	000	3	1/14/2026	NON-COMPETING CONTINUATION	-$5,023
														Subtotal = -$5,023

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	UNIVERSITY OF DETROIT MERCY	4001 W MCNICHOLS RD	DETROIT	MI	48221	WAYNE	USA	Food and Drug Administration Research	000	3	7/31/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $99,828 )
2023	2023	UNIVERSITY OF DETROIT MERCY	4001 W MCNICHOLS RD	DETROIT	MI	48221	WAYNE	USA	Food and Drug Administration Research	000	3	8/14/2023	NON-COMPETING CONTINUATION	$99,828
														Subtotal = $99,828

Issue Date FY: 2022 ( Subtotal = $199,357 )
2022	2022	UNIVERSITY OF DETROIT MERCY	4001 W MCNICHOLS RD	DETROIT	MI	48221	WAYNE	USA	Food and Drug Administration Research	000	2	9/6/2022	NON-COMPETING CONTINUATION	$199,357
														Subtotal = $199,357

Issue Date FY: 2021 ( Subtotal = $195,897 )
2021	2021	UNIVERSITY OF DETROIT MERCY	4001 W MCNICHOLS RD	DETROIT	MI	48221	WAYNE	USA	Food and Drug Administration Research	000	1	7/20/2021	NEW	$195,897
														Subtotal = $195,897

Grand Total All Awards = $490,059

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Development of a Combination Product Taxonomy and Comparative Human Factors Testing Method for Drug-Device Combination Products Submitted in an ANDA

Award Number: U01FD007360

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2021

PERIOD OF PERFORMANCE END DATE: 07/31/2025

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