forecasted
Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed
Food and Drug Administration · FOR-FD-24-003
$300,000 – $300,000
Not specified
Special district governments, Public and State controlled institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, City or township governments, Small businesses, Native American tribal governments (Federally recognized), Independent school districts, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, State governments, Public housing authorities/Indian housing authorities, Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility", County governments
Geographic eligibility and all attachment-specific conditions require review of the original announcement.
Eligibility details
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Matching funds & resources
Source matching-funds field: Not Required.
Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.
About this opportunity
Complex generic drug products represent an increasing share of the generic marketplace and may have distinct user interface differences compared to reference listed drug (RLD) products. A modernized post-market surveillance approach is needed to compare clinical outcomes between complex generic products and their corresponding RLD products to monitor for potential issues with therapeutic equivalence and to inform regulatory decision making. Real-world data (RWD) combined with machine learning (ML) and/or artificial intelligence (AI) could help to identify post-market signals efficiently in an automated and repeatable fashion, facilitating timely regulatory action. The purpose of this funding opportunity is to develop and test an AI- or ML-based algorithmic RWD model for post-market surveillance of complex generic drug products.
Funding geography: Not specified — review source. A funder’s address does not establish eligibility.
Review original source ↗Funding instrument: Cooperative Agreement. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.
Source fields and evidence
id: 351125
Source ↗ · id
opportunityNumber: FOR-FD-24-003
Source ↗ · opportunityNumber
opportunityTitle: Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed
Source ↗ · opportunityTitle
revision: 2
Source ↗ · revision
agencyDetails: {"code":"FDA","seed":"HHS-FDA","agencyName":"Food and Drug Administration","agencyCode":"HHS-FDA","topAgencyCode":"HHS"}
Source ↗ · agencyDetails
owningAgencyCode: HHS-FDA
Source ↗ · owningAgencyCode
cfdas: [{"id":415633,"opportunityId":351125,"cfdaNumber":"93.103","programTitle":"Food and Drug Administration Research"}]
Source ↗ · cfdas
forecastDesc: <p><span style="color: black;">Complex generic drug products represent an increasing share of the generic marketplace and may have distinct user interface differences compared to reference listed drug (RLD) products. A modernized post-market surveillance approach is needed to compare clinical outcomes between complex generic products and their corresponding RLD products to monitor for potential issues with therapeutic equivalence and to inform regulatory decision making. Real-world data (RWD) combined with machine learning (ML) and/or artificial intelligence (AI) could help to identify post-market signals efficiently in an automated and repeatable fashion, facilitating timely regulatory action. The purpose of this funding opportunity is to develop and test an AI- or ML-based algorithmic RWD model for post-market surveillance of complex generic drug products. </span></p>
Source ↗ · forecastDesc
applicantTypes: [{"id":"04","description":"Special district governments"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"20","description":"Private institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"02","description":"City or township governments"},{"id":"23","description":"Small businesses"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"05","description":"Independent school districts"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"00","description":"State governments"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"99","description":"Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled \"Additional Information on Eligibility\""},{"id":"01","description":"County governments"}]
Source ↗ · applicantTypes
applicantEligibilityDesc: Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Source ↗ · applicantEligibilityDesc
fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
Source ↗ · fundingInstruments
fundingActivityCategories: [{"id":"AG","description":"Agriculture"},{"id":"CP","description":"Consumer Protection"},{"id":"FN","description":"Food and Nutrition"}]
Source ↗ · fundingActivityCategories
awardFloor: 300000
Source ↗ · awardFloor
awardCeiling: 300000
Source ↗ · awardCeiling
costSharing: false
Source ↗ · costSharing
lastUpdatedDate: Nov 24, 2023 12:53:52 PM EST
Source ↗ · lastUpdatedDate
status: forecasted
Source ↗ · oppHits[id=351125].oppStatus
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