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
This is a forecasted opportunity — a pre-announcement that isn’t open for applications yet. Dates and details may change before it posts.
This is a forecasted FDA research opportunity (U01, no clinical trials) to use real-world data and algorithmic analysis to assess post-market clinical outcomes for patients switching between therap…
- Deadline
- Not specified
- Posted
- Nov 24, 2023
- Award amount
- Amount not specified
In plain English
This is a forecasted FDA research opportunity (U01, no clinical trials) to use real-world data and algorithmic analysis to assess post-market clinical outcomes for patients switching between therapeutically equivalent complex generic drugs and their reference drugs. Eligibility, award amounts, and deadlines are not yet announced; such cooperative agreements generally support universities and research institutions with relevant data and pharmacology expertise. Review the official notice when published to confirm requirements.
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