Opportunity ID: 351805
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-007 |
| Funding Opportunity Title: | 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 |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Jan 15, 2024 |
| Last Updated Date: | Apr 02, 2024 |
| Original Closing Date for Applications: | Mar 31, 2024 |
| Current Closing Date for Applications: | Apr 08, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses City or township governments Special district governments Native American tribal governments (Federally recognized) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” State governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
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. |
| Link to Additional Information: | RFA-FD-24-007 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| The deadline has been extended to April 8, 2024. | Apr 02, 2024 | |
| The closing date was incorrect on grants.gov. | Jan 15, 2024 | |
| The link to the full announcement has been added. | Jan 15, 2024 | |
| Jan 15, 2024 |
DISPLAYING: Synopsis 4
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-007 |
| Funding Opportunity Title: | 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 |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 4 |
| Posted Date: | Jan 15, 2024 |
| Last Updated Date: | Apr 02, 2024 |
| Original Closing Date for Applications: | Mar 31, 2024 |
| Current Closing Date for Applications: | Apr 08, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses City or township governments Special district governments Native American tribal governments (Federally recognized) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” State governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
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. |
| Link to Additional Information: | RFA-FD-24-007 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-007 |
| Funding Opportunity Title: | 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 |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Jan 15, 2024 |
| Last Updated Date: | Apr 01, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Apr 01, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Special district governments Public and State controlled institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts State governments Small businesses |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
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. |
| Link to Additional Information: | RFA-FD-24-007 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-007 |
| Funding Opportunity Title: | 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 |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Jan 15, 2024 |
| Last Updated Date: | Mar 14, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Mar 31, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Special district governments Public and State controlled institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts State governments Small businesses |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
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. |
| Link to Additional Information: | RFA-FD-24-007 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-007 |
| Funding Opportunity Title: | 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 |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jan 15, 2024 |
| Last Updated Date: | Jan 15, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Mar 31, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $300,000 |
| Award Ceiling: | $300,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Special district governments Public and State controlled institutions of higher education Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts State governments Small businesses |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
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. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Phone 2404027610 Email:terrin.brown@fda.hhs.gov |
Related Documents
Packages
| Agency Contact Information: | Terrin Brown Grantor Email: terrin.brown@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-24-007 | FORM H | PKG00284420 | Jan 15, 2024 | Apr 08, 2024 | View |
Package 1
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