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Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required

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Contract Overview

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

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The Food and Drug Administration, under the Department of Health and Human Services, is issuing a forecast for R01 clinical trials focused on rare neurodegenerative diseases affecting both children and adults. The primary objective of this initiative is to fund trials that evaluate the safety and efficacy of products to support new indications or changes in labeling, specifically targeting unmet medical needs. By promoting collaborative and innovative clinical trial designs, the agency aims to increase the availability of approved treatments and positively influence the broader landscape of rare disease drug development. Interested parties can contact Terrin Brown for further information regarding this opportunity.

General Info

Funds clinical trials for rare neurodegenerative diseases in children and adults to accelerate therapy approvals.

Agency

Department Of Health And Human Services → Food And Drug Administration

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PostedAug 14

forecast

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Food And Drug Administration

Contacts1 person available

OfficeUSA

Organization / Agency

Department Of Health And Human Services → Food And Drug Administration

Office AddressUSA

Contacts

Terrin Brown Grantor

contact@example.gov

+1 (555) 000-0000

Full Description

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The purpose is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare neurodegenerative diseases for children and adults. Through the support of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare neurodegenerative diseases and exert a broad and positive impact on rare disease drug development.

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