What does FDA Center For Drug Evaluation And Research do?

The FDA Center for Drug Evaluation and Research is tasked with ensuring the safety, efficacy, and quality of pharmaceutical products through scientific evaluation and regulatory oversight. Its core mission centers on advancing evidence-based decision-making in drug review, leveraging advanced analytical technologies, computational modeling, and data-driven research to assess new therapeutics and generic drug applications. Strategic priorities include enhancing product assessment capabilities through artificial intelligence, advanced imaging, and simulation tools, particularly for complex generics, while strengthening post-market surveillance systems like Sentinel. The agency prioritizes innovation in drug development pathways and supports the adoption of next-generation analytical platforms to accelerate regulatory science. Procurement patterns reveal a strong emphasis on professional scientific and technical services, particularly in research and development, data infrastructure, and specialized software support. The agency frequently engages contractors for analytical laboratory instrumentation, computational modeling, cloud-based data processing, and AI-assisted image analysis to support regulatory evaluations. Contracts are typically awarded through combined or sole-source mechanisms, reflecting the need for specialized expertise and proprietary technologies that align with evolving scientific standards. Industry preferences are concentrated in analytical instrument manufacturing, life sciences R&D, and computing infrastructure services, with a clear focus on vendors capable of delivering validated, compliant, and scalable scientific solutions. The agency shows a pronounced reliance on small business set-asides, particularly under the SBA program, indicating a strategic commitment to fostering innovation among niche technical providers. Vendor relationships are characterized by long-term partnerships with firms possessing deep domain expertise in pharmaceutical analytics and regulatory science. As a component of the Food and Drug Administration under the Department of Health and Human Services, the Center operates nationally with no single geographic footprint, coordinating with field offices and external research partners. It utilizes a mix of indefinite-delivery/indefinite-quantity (IDIQ) contracts, sole-source awards, and research collaborations to procure mission-critical scientific and technical services.

What contracts does FDA Center For Drug Evaluation And Research award?

FDA Center For Drug Evaluation And Research awards government contracts across various categories. Browse contract opportunities from this agency.

How do I do business with FDA Center For Drug Evaluation And Research?

To do business with FDA Center For Drug Evaluation And Research, start by registering in SAM.gov and obtaining a UEI number. Then search for contract opportunities from this agency on CLEATUS. Review the agency's procurement history, identify relevant NAICS codes, and prepare competitive proposals. The contractors tab shows companies that have won contracts from this agency.

Who are the top contractors for FDA Center For Drug Evaluation And Research?

View the full list of contractors who have won awards from FDA Center For Drug Evaluation And Research in the contractors tab . You can filter by contract value, NAICS code, and set-aside type to find relevant competitors and potential teaming partners.

What set-aside programs does FDA Center For Drug Evaluation And Research use?

FDA Center For Drug Evaluation And Research uses 5 different set-aside programs, including Total Small Business Set-Aside (FAR 19.5), 8a Competed, 8(a) Sole Source, and HUBZone Set Aside. These programs reserve a portion of contracts for qualifying businesses. View the set-aside breakdown on the agency overview.

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Federal Agency· 75DKKN

FDA Center For Drug Evaluation And Research

Part of Department Of Health And Human Services

The FDA Center for Drug Evaluation and Research is tasked with ensuring the safety, efficacy, and quality of pharmaceutical products through scientific evaluation and regulatory oversight. Its core mission centers on advancing evidence-based decision-making in drug review, leveraging advanced analytical technologies, computational modeling, and data-driven research to assess new therapeutics and generic drug applications.

Company	Total Awards	Contracts
SOURCE HEALTHCARE ANALYTICS, LLC Blue Bell PA USA	$45.0M	1
WYATT TECHNOLOGIES LLC UT 84404-8537 USA	$492K	1

FDA Center For Drug Evaluation And Research

Part of Department Of Health And Human Services

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Advanced Manufacturing Technologies In-Person Training Program

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Instruction by Subject Matter Experts in Advanced Manufacturing Technologies

Advanced Pharmaceutical Manufacturing Training Curriculum Development

Past Performance Reference Validation and Client Reporting

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Frequently Asked Questions

What does FDA Center For Drug Evaluation And Research do?

What contracts does FDA Center For Drug Evaluation And Research award?

How do I do business with FDA Center For Drug Evaluation And Research?

Who are the top contractors for FDA Center For Drug Evaluation And Research?

What set-aside programs does FDA Center For Drug Evaluation And Research use?

Recently Posted by FDA Center For Drug Evaluation And Research

Get AI-powered intelligence on FDA Center For Drug Evaluation And Research procurement

Leadership and vacancies

Recent FDA Center For Drug Evaluation And Research Contracts

Advanced Manufacturing Technologies In-Person Training Program

Pharmaceutical Manufacturing Hands-On Short Courses

On-Site Training Logistics and Event Coordination

Instruction by Subject Matter Experts in Advanced Manufacturing Technologies

Advanced Pharmaceutical Manufacturing Training Curriculum Development

Past Performance Reference Validation and Client Reporting

Training Materials and Courseware Production

Plumbing and Piping Systems Installation

HVAC System Installation

Roofing System Installation

Search all FDA Center For Drug Evaluation And Research contracts

Top FDA Center For Drug Evaluation And Research Contractors

Search all FDA Center For Drug Evaluation And Research contractors

Frequently Asked Questions

What does FDA Center For Drug Evaluation And Research do?

What contracts does FDA Center For Drug Evaluation And Research award?

How do I do business with FDA Center For Drug Evaluation And Research?

Who are the top contractors for FDA Center For Drug Evaluation And Research?

What set-aside programs does FDA Center For Drug Evaluation And Research use?