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Drug Repurposing Accelerator and Regulatory Roadmap

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The Drug Repurposing Accelerator and Regulatory Roadmap subcontract, managed by the FDA Negotiated Contracts Branch within the Department of Health and Human Services, focuses on developing a regulatory pathway for drug repurposing. The selected contractor will organize and facilitate approximately 11 virtual biweekly expert meetings for prime contractors, requiring a high level of expertise in FDA regulatory approval processes. Key deliverables include the preparation of public meeting summaries for the RUF website, a comprehensive final synthesis report of identified themes, and the publication of a Regulatory Roadmap. The performance of these services is centered in Silver Spring, Maryland, under NAICS code 541611.

General Info

FDA subcontract to develop a drug repurposing regulatory roadmap via expert virtual meetings.

Agency

Department Of Health And Human Services → FDA Negotiated Contracts BranchView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

This scope was carved out of FDASSOC136354.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

The Food and Drug Administration (FDA) intends to award a sole source contract to the Reagan-Udall Foundation for the FDA (RUF) to support execution of its ts congressionally mandated regulatory mission across 16 project areas

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Negotiated Contracts Branch
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → FDA Negotiated Contracts Branch
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Office AddressN/A
ContactsNo contact information available

Full Description

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Convenes expert meetings for prime contractors on FDA projects to develop a regulatory pathway for drug repurposing. Manages approximately 11 virtual biweekly meetings, prepares public meeting summaries for the RUF website, and synthesizes themes into a final report. Requires deep knowledge of FDA regulatory pathways for drug approval. Delivers meeting summaries, a final synthesis report, and a published Regulatory Roadmap.

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