[Food and Drug Administration](https://www.fda.gov/)

Forecasted (Estimated; not yet open)

Up to $500,000 per award; minimum $250,000; up to 2 awards; duration not specified.

Supports research to improve prediction of food-drug and drug-drug interaction risks for high-risk oral drugs using in vitro GI dissolution models.

This is a forecasted opportunity; application details and deadlines are not yet available.

--- ## Description This funding opportunity from the Food and Drug Administration (FDA) aims to advance the predictability of food-drug and drug-drug interaction risks for high-risk oral drug products. The focus is on developing and validating in vitro simulated gastrointestinal (GI) dissolution models to assess the performance of amorphous solid dispersion (ASD) drug products under clinically relevant conditions. The ultimate goal is to create mechanistic methodologies that correlate in vitro results with in vivo outcomes, thereby informing regulatory decisions, defining bioequivalence study requirements, and mitigating risks associated with therapeutic equivalence for generic oral drugs. --- ## Due Dates - This is a **forecasted opportunity**; specific application due dates have not yet been announced. - Researchers should monitor [Grants.gov](https://www.grants.gov/search-results-detail/351127) for updates on the official release and deadlines. --- ## Funding Amount - **Award Ceiling:** $500,000 per award - **Award Floor:** $250,000 per award - **Expected Number of Awards:** 2 - **Funding Instrument:** Cooperative Agreement - **Project duration:** Not specified in the forecast No cost sharing or matching is required. --- ## Eligibility Eligible applicants include: - Public and State controlled institutions of higher education - Private institutions of higher education - State, county, city, or township governments - Special district governments - Independent school districts - Native American tribal governments (federally recognized and other organizations) - Public housing authorities/Indian housing authorities - Nonprofits with or without 501(c)(3) status (excluding higher education institutions) - For-profit organizations (including small businesses) - Others and unrestricted entities, subject to clarification in the full announcement **Additional notes:** - Organizations may submit more than one application if each is scientifically distinct. - Duplicate or highly overlapping applications will not be accepted for review at the same time. --- ## Application Process - As this is a **forecasted opportunity**, the application package and instructions are not yet available. - Interested applicants should regularly check the [Grants.gov opportunity page](https://www.grants.gov/search-results-detail/351127) for updates, including the official Notice of Funding Opportunity (NOFO), application instructions, and deadlines. - Applications will be submitted electronically via Grants.gov once the opportunity is posted. --- ## Additional Information - Clinical trials are optional under this opportunity. - The research should focus on the development and validation of in vitro GI dissolution models for ASD drug products, with the aim of improving regulatory science and public health outcomes. - The results are expected to inform regulatory decision-making, particularly regarding bioequivalence and risk mitigation for high-risk generic oral drugs. --- ## External Links - [FDA Funder Homepage](https://www.fda.gov/) - [Grants.gov Opportunity Listing](https://www.grants.gov/search-results-detail/351127) - [FDA Contact Page](https://www.fda.gov/about-fda/contact-fda) --- ## Contact Information | Name | Role | Email | Phone | |--------------|---------|-----------------------------------------|-----------------| | Terrin Brown | Grantor | [terrin.brown@fda.hhs.gov](mailto:terrin.brown@fda.hhs.gov) | (240) 402-7610 | | FDA General | | [patientaffairs@fda.hhs.gov](mailto:patientaffairs@fda.hhs.gov) | (888) 463-6332 |

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

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