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
- Award ceiling
- $300,000
- Closes
- Not stated
- Last verified
- 2026-10-15
Awards $300,000 per recipient for city or township governments, county governments, for profit organizations other than small businesses, independent school districts, native american tribal governments (federally recognized), native american tribal organizations (other than federally recognized tribal governments), 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, private institutions of higher education, public and state controlled institutions of higher education, public housing authorities/indian housing authorities, small businesses, special district governments, state governments, unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "additional information on eligibility".
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 city or township…
- Program pool (total)
- Not confirmedTotal across all awards in this programme. Not an amount any single applicant can receive.
- Award ceiling (per project)
- $300,000
- Award floor
- $300,000
- Typical award
- Not confirmed
- Deadline
- Not stated
- Deadline type
- Not stated
- Opens
- Not stated
- Status
- Forecasted
- Eligible entities
- City or township governments · County governments · For profit organizations other than small businesses · Independent school districts · Native American tribal governments (Federally recognized) · Native American tribal organizations (other than Federally recognized tribal governments) · 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 · Private institutions of higher education · Public and State controlled institutions of higher education · Public housing authorities/Indian housing authorities · Small businesses · Special district governments · State governments · 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
- Use of funds
- develop and test an AI- or ML-based algorithmic RWD model for post-market surveillance of complex generic drug products
- 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.
Who can apply?
+5more
, Public housing authorities/Indian housing authorities, Small businesses, Special district governments, State governments, Open to any applicantNot confirmed
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 per 2.3.7.4…
We store the structured fields above. Clause-by-clause text from the guidelines is not connected for this record.When does it close?
What can the money be used for?
1 categoryThe source’s own spending categories, and what is not parsed.
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?
1 fieldEffort, match requirement and reimbursement, as the source stated them.
- Application effort
- Not confirmed
- Disbursement
- Not confirmed
- Matching funds
- No
What comparable notices state
66 recordsStated ceilings on open records in the same industry.
Among open records stored under Agriculture, 66 of 80 state an award ceiling. Those that do run:
- 25th percentile$312,500
- Median$1,000,000
- 75th percentile$2,000,000
A statistical estimate, not a prediction. It describes what a set of notices has published in this catalogue on the day you read it, and says nothing about what this programme will award. Records stating no ceiling are excluded rather than counted as zero, and the programme pool — what a funder has across every applicant — is a different column and is never mixed in.
Who has won this programme before?
1262 awardsAwards under the same assistance listing, not under this notice.
1262 federal awards on file under assistance listing 93.103, the programme this notice is published under. These are not awards made under this notice — a listing covers every year the programme runs, and awards under an open notice do not exist yet.
- $121,795,918THE CRITICAL PATH INSTITUTEAZ · FY2014
- $76,105,626THE MEDICAL DEVICE INNOVATION CONSORTIUMVA · FY2018
- $52,265,594UNIVERSITY OF MARYLAND, COLLEGE PARKMD · FY1997
- $47,940,304ILLINOIS INSTITUTE OF TECHNOLOGYIL · FY2014
- $36,000,000NATIONAL ENVIRONMENTAL HEALTH ASSOCIATIONCO · FY2021
Common questions
4 questionsEvery answer 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.
- Who is eligible to apply?
- City or township governments, County governments, For profit organizations other than small businesses, Independent school districts, Native American tribal governments (Federally recognized), Native American tribal organizations (other than Federally recognized tribal governments), 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, Private institutions of higher education, Public and State controlled institutions of higher education, Public housing authorities/Indian housing authorities, Small businesses, Special district governments, State governments, 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?
- develop and test an AI- or ML-based algorithmic RWD 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.
AI summary of the source text
Optional. Every core field on this record is already above, free and complete.
AI summary of the source text
Studio reads this record’s stored eligibility and materials text and breaks it into separate points, each quoting the exact words it came from. It never writes application prose, never guesses at a field the source did not state, and never estimates anyone’s chances.
Included with Studio
Sign inWhat else is open
- Novel approaches to support therapeutic development in ultra-rare cancersCloses Not statedAwards Not stated
- Data Standards for Tobacco Research and Scientific Review Phase 2Closes Not statedAwards Not stated
- Rapid Response Team (RRT) Cooperative AgreementCloses Not statedAwards Not stated
- FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)Closes Not statedAwards Not stated
- Manufactured Foods Flexible Funding Model (MF-FFM)Closes Not statedAwards Not stated
- African Medical Devices Regulatory Harmonization ProgramCloses Not statedAwards Not stated
A listing names the programme; a notice names one round of it. These are other rounds open now, not other years of this one.
- Novel approaches to support therapeutic development in ultra-rare cancersCloses Not statedAwards Not stated
- Data Standards for Tobacco Research and Scientific Review Phase 2Closes Not statedAwards Not stated
- Rapid Response Team (RRT) Cooperative AgreementCloses Not statedAwards Not stated
- FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed)Closes Not statedAwards Not stated
- Manufactured Foods Flexible Funding Model (MF-FFM)Closes Not statedAwards Not stated
- African Medical Devices Regulatory Harmonization ProgramCloses Not statedAwards Not stated
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.