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Center for Research on Complex Generics

Award Number: U18FD007054
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)
PERIOD OF PERFORMANCE START DATE: 08/01/2020
PERIOD OF PERFORMANCE END DATE: 12/31/2026

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Center for Research on Complex Generics - Project Summary: We propose a Center for Research on Complex Generics (CRCG), which will serve the public by working with the Food and Drug Administration (FDA) and the generic drug industry to identify and organize activities that promote the development of complex generics, including greater first cycle approvals. CRCG will be a science- based resource that adds to ongoing FDA Office of Generic Drugs (OGD) activities, with a focus on complex generics and opportunity to learn about, and contribute to, complex generic drug development. This viewpoint reflects the perspective that pre-competitive spaces in drug development science, including complex formulation science, are public spaces that require active public involvement. We will work with the best content experts to move pharmaceutical development science for more accessible medicines forward. The mission of the CRCG is to support the FDA's efforts to enhance research collaborations with the generic industry to further the FDA's mission of increasing access to safe and effective generic drugs. This mission will be pursued through collaborative research, training, and exchange. Stakeholders include FDA, the generic industry, and all others with an interest in better pharmaceutical development science for more accessible medicines. Activities include webinars, workshops, pilot laboratory projects to meet technique development needs, laboratory demonstrations, a Visiting Scientist Program, as well as a Complex Generics Scholars program and student events. The sum of these activities describe a vibrant, cutting edge Center that stimulates innovative thought, disseminates understanding of complex drugs and practices, and generates new knowledge in support of the FDA's fundamental mission – to promote and protect the public health.


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 = $1,500,000 )
2026	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	000	5	12/29/2025	NON-COMPETING CONTINUATION	$1,500,000
														Subtotal = $1,500,000

Issue Date FY: 2025 ( Subtotal = $500,000 )
2025	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	000	5	6/11/2025	NON-COMPETING CONTINUATION	$0
2025	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	001	5	7/24/2025	NON-COMPETING CONTINUATION	$500,000
														Subtotal = $500,000

Issue Date FY: 2024 ( Subtotal = $1,000,000 )
2024	2024	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	000	5	9/10/2024	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2023 ( Subtotal = $1,250,000 )
2023	2023	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	000	4	7/25/2023	NON-COMPETING CONTINUATION	$1,000,000
2023	2023	UNIVERSITY OF MARYLAND, BALTIMORE	220 ARCH ST OFC LEVEL2	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	001	4	9/14/2023	SUPPLEMENT FOR EXPANSION	$250,000
														Subtotal = $1,250,000

Issue Date FY: 2022 ( Subtotal = $1,000,000 )
2022	2022	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	000	3	8/15/2022	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2021 ( Subtotal = $1,000,000 )
2021	2021	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	001	2	8/13/2021	NON-COMPETING CONTINUATION	$1,000,000
2021	2020	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	000	1	7/20/2021	NEW	$0
														Subtotal = $1,000,000

Issue Date FY: 2020 ( Subtotal = $1,000,000 )
2020	2020	UNIVERSITY OF MARYLAND	220 ARCH ST RM 02148	BALTIMORE	MD	21201	BALTIMORE CITY	USA	Food and Drug Administration Research	000	1	7/10/2020	NEW	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $7,250,000

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Center for Research on Complex Generics

Award Number: U18FD007054

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

PERIOD OF PERFORMANCE START DATE: 08/01/2020

PERIOD OF PERFORMANCE END DATE: 12/31/2026

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