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Forecasted

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

This forecast was posted November 24, 2023 and last updated November 30, 2023. A forecast is an agency’s statement of planned funding rather than an open opportunity, and this one has not moved in over a year. Agencies do not always withdraw plans they have dropped, so confirm it on the official listing at Grants.gov before building plans around it.

View forecast on Grants.gov →Forecasted — not yet open · no update since November 30, 2023

Posted
November 24, 2023
Closes
See announcement
Award ceiling
$500,000
Award floor
$250,000
Expected awards
2
Cost sharing
No
Instrument
Cooperative Agreement
Assistance listing
93.103
Category
Agriculture, Consumer Protection, Food and Nutrition

Program funding history

Awards made under Assistance Listing 93.103 across FY2025–FY2027, from public federal spending records.

FY2025 obligated
$213M
FY2026 obligated
$215.3M
FY2027 (to date) obligated
$0
Awards in window
849

Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, Yale Univ, Food & Agriculture, California Department of

Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →

Synopsis

The purpose of this funding opportunity is to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions. The goal is to develop and validate the in vitro mechanistic methodology to provide an improved understanding of impact of food and acid reducing agents on the absorption for test and reference listed drug (RLD) drug products, taking into consideration their potentially different formulations and manufacturing. The bio predictive in vitro mechanistic methodology is intended to correlate the in vitro observations to in vivo outcomes, help define types of in vivo bioequivalence (BE) studies needed for ASD drug products, and inform regulatory decision-making related to mitigating the risk of potential failure modes for therapeutic equivalence for high-risk generic oral drug products. 

Who can apply

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).

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov

Agency contact: Terrin Brown Grantor · [email protected] · (240) 402-7610

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