NIH R01 to run clinical trials for orphan drug new indications or label changes in rare diseases
This NIH R01 opportunity funds clinical studies required to evaluate the efficacy and/or safety of orphan products for a new indication or to support changes in labeling for rare diseases. It also supports collaborative, efficient, or innovative trial designs to help increase the number of approved treatments. Clinical trials are required under this program.
The purpose of this opportunity 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 diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovat…
Funding Source
Eligibility
Higher Education Institutions
Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits witho…
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