OtherForecastedForecastedFood and Drug Administration

Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional

Awards $250,000 – $500,000 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, closing Forecasted — not yet open.

In one sentence

Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional awards $250,000 – $500,000 per recipient, open to business, city or township governments, county…

Record fields
Program pool (total)
Not confirmed
Total across all awards in this programme. Not an amount any single applicant can receive.
Award ceiling (per project)
$500,000
Award floor: $250,000; Award ceiling: $500,000. Expected number of awards: 2.
Award floor
$250,000
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
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.

Program pool (total)Across all awards this cycle
Not stated
Award ceiling (per project)The most one applicant can receive
$500,000

Source wording: “Award floor: $250,000; Award ceiling: $500,000. Expected number of awards: 2.

Who can apply?

industry
use

Assessment of impact of food and acid reducing agents on drug absorption, Bioequivalence studies for amorphous solid dispersion drug products, Development and validation of in vitro mechanistic methodology, Examination of utility of in vitro simulated gastrointestinal dissolution model for assessment of amorphous solid dispersion drug products

Source field: use of funds
size limit

Not stated

Source field: applicant size limit
clause text

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.

We store the structured fields above. Clause-by-clause text from the guidelines is not connected for this record.

When does it close?

Forecasted — not yet openforecasted deadline

Opportunity status is forecasted; no specific deadline date provided.

What can the money be used for?

Examination of utility of in vitro simulated gastrointestinal dissolution model for assessment of amorphous solid dispersion drug productsDevelopment and validation of in vitro mechanistic methodologyAssessment of impact of food and acid reducing agents on drug absorptionBioequivalence studies for amorphous solid dispersion drug products

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
No
Cost sharing: 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?
$250,000 – $500,000 per recipient. The source states: “Award floor: $250,000; Award ceiling: $500,000. Expected number of awards: 2.”.
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.
What can the funding be used for?
Examination of utility of in vitro simulated gastrointestinal dissolution model for assessment of amorphous solid dispersion drug products, Development and validation of in vitro mechanistic methodology, Assessment of impact of food and acid reducing agents on drug absorption, Bioequivalence studies for amorphous solid dispersion drug products, as classified by the source.
Is matching funding required?
No. The source states that no matching funds are required. Cost sharing: false
Provenance
Source pagegrants.gov
Retrieved2026-08-31
MethodAutomated check
First seen2026-08-31

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.