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
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you have real-world clinical datasets and can build analytics showing whether generic complex drugs match brand equivalents, FDA will fund your research.
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What this is
This FDA-sponsored research opportunity seeks to evaluate how patients fare when switching between therapeutically equivalent complex generic drugs and reference listed (brand-name) drugs using real-world clinical data and algorithmic methods. The study focuses on post-market outcomes assessment rather than controlled trials, making it suitable for health data analytics and pharmacoeconomic research organizations. This addresses a critical gap in understanding whether generic complex drugs perform identically to brand-name drugs in actual patient populations.
Who can apply
Eligibility criteria are unspecified in the provided text. Based on CFDA 93.103 (FDA grants), typically universities, research institutions, non-profits, and eligible small businesses may apply; contact the FDA for confirmation of eligible applicant types for this specific U01 notice.
Topics: real-world evidence · generic drug substitution · post-market surveillance · clinical outcomes · algorithmic analysis · complex generics · FDA pharmacovigilance
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.