Scout | AI/ML real-world data study to monitor outcomes when patients switch between complex generics and reference drugs

This opportunity is no longer accepting applications.

forecast

AI/ML real-world data study to monitor outcomes when patients switch between complex generics and reference drugs

This opportunity would fund teams to develop and test an AI/ML-based real-world data model for post-market surveillance of complex generic drug products. The goal is to compare patient clinical outcomes between complex generics and their corresponding reference listed drugs, helping regulators detect potential therapeutic equivalence issues efficiently. Note: this is labeled “Clinical Trial No…

Source

Agency: Food and Drug Administration

Award

Award Ceiling: $300,000

Award Floor: $300,000

Eligibility

government

nonprofit

small_business

tribal

university

For profit organizations other than small businesses

Native American tribal governments (Federally recognized)

Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education

Private institutions of higher education

State governments

Keywords

real-world data

post-market surveillance

complex generics

machine learning

ai algorithms

therapeutic equivalence

drug switching

regulatory science

Supporting Links

Documents

Similar Opportunities

Unlock similar opportunities

Get the full picture on this opportunity

Create a free Scout account to unlock everything you need to decide fast and win the grant.

Instant Fit Analysis

Let our grant expert AI score how well this opportunity aligns with your organization, strengths, gaps, and how to improve your chances of winning funding.
Deep agency & funder detail

Program context, sub-agency structure, and a full eligibility breakdown.
Source links & full documents

Jump straight to the solicitation and download every attachment.
Similar opportunities

Discover related funding matched to your work.

Get a Demo Sign Up

Already have an account? Sign In

Trusted by 500+ Happy Customers