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
Awards $300,000 per recipient for business, city or township governments, county governments, for profit organizations other than small businesses, independent school districts, individual, native american tribal governments (federally recognized), native american tribal organizations (other than federally recognized tribal governments), nonprofit, nonprofits having a 501(c)(3) status with the irs, other than institutions of higher education, nonprofits that do not have a 501(c)(3) status with the irs, other than institutions of higher education, other legal entity, private institutions of higher education, public agency, public and state controlled institutions of higher education, public housing authorities/indian housing authorities, small businesses, special district governments, state governments, tribal government, unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled additional information on eligibility, closing Forecasted — not yet open.
In one sentence
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 awards $300,000 per recipient, open to business, city or…
- Program pool (total)
- Not confirmedTotal across all awards in this programme. Not an amount any single applicant can receive.
- Award ceiling (per project)
- $300,000Award floor and ceiling are both $300,000. Expected number of awards is 1.
- Award floor
- $300,000
- Typical award
- Not confirmed
- Deadline
- Forecasted — not yet open
- Deadline type
- forecasted
- Opens
- Not stated
- Status
- Forecasted
- Eligible entities
- Business · City or township governments · County governments · For profit organizations other than small businesses · Independent school districts · Individual · Native American tribal governments (Federally recognized) · Native American tribal organizations (other than Federally recognized tribal governments) · Nonprofit · Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education · Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education · Other Legal Entity · Private institutions of higher education · Public Agency · Public and State controlled institutions of higher education · Public housing authorities/Indian housing authorities · Small businesses · Special district governments · State governments · Tribal Government · Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility
- Geography
- Not stated
- Matching funds
- No
- Disbursement
- Not confirmed
- Application effort
- Not confirmed
- Currency
- USD
How much money is available?
Two different figures govern a programme and they are not interchangeable. The programme pool is what the funder has allocated across every award it will make this cycle. The award ceiling is the most one applicant can be granted.
Source wording: “Award floor and ceiling are both $300,000. Expected number of awards is 1.”
Who can apply?
Business, City or township governments, County governments, For profit organizations other than small businesses, Independent school districts, Individual, Native American tribal governments (Federally recognized), Native American tribal organizations (other than Federally recognized tribal governments), Nonprofit, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Other Legal Entity, Private institutions of higher education, Public Agency, Public and State controlled institutions of higher education, Public housing authorities/Indian housing authorities, Small businesses, Special district governments, State governments, Tribal Government, Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility
Source field: entity typesAgriculture, Consumer Protection, Food and Nutrition
Source field: industriesDevelopment and testing of AI- or ML-based algorithmic real-world data model for post-market surveillance of complex generic drug products
Source field: use of fundsNot stated
Source field: applicant size limitApplicant 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.
We store the structured fields above. Clause-by-clause text from the guidelines is not connected for this record.When does it close?
Opportunity status is forecasted; no deadline has been announced.
What can the money be used for?
These categories come from the source's own classification. A line-item cost table, where the programme publishes one, lives in the guidelines and is not parsed for this record.
How hard is the application?
- Application effort
- Not confirmed
- Disbursement
- Not confirmed
- Matching funds
- NoCost sharing is false.
Who has received this funding?
No award records yet
We hold no prior awards for this programme. That is a gap in what we have connected, not a finding that the programme has never funded anyone — check the official page, which may list past recipients.
Common questions
Every answer below is a stored field from this record. Questions the source did not answer are not asked.
- How much can one applicant receive?
- $300,000 per recipient. The source states: “Award floor and ceiling are both $300,000. Expected number of awards is 1.”.
- Who is eligible to apply?
- Business, City or township governments, County governments, For profit organizations other than small businesses, Independent school districts, Individual, Native American tribal governments (Federally recognized), Native American tribal organizations (other than Federally recognized tribal governments), Nonprofit, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Other Legal Entity, Private institutions of higher education, Public Agency, Public and State controlled institutions of higher education, Public housing authorities/Indian housing authorities, Small businesses, Special district governments, State governments, Tribal Government, Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
- What can the funding be used for?
- Development and testing of AI- or ML-based algorithmic real-world data model for post-market surveillance of complex generic drug products, as classified by the source.
- Is matching funding required?
- No. The source states that no matching funds are required. Cost sharing is false.
The official page governs. If the source and this record disagree, the source is correct — programmes change their terms between our checks, so confirm every figure above before you apply.