Scout | FDA Cooperative Agreement for a Human Abuse Potential Clinical Study of Botanical Kratom (U01)

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FDA Cooperative Agreement for a Human Abuse Potential Clinical Study of Botanical Kratom (U01)

FDA is funding development and execution of a human abuse potential study for botanical kratom, using clinical trial methods required for this type of assessment. Applicants must design the study per FDA guidance on abuse potential, including appropriate comparators and outcomes, and also handle IND submission and IRB approval. The goal is to generate clinical evidence on kratom’s potential fo…

Source

Agency: Food and Drug Administration

Award

Award Ceiling: $2M

Award Floor: $2M

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

fda

kratom

abuse potential

clinical trial

u01

human subjects

ind application

irb clearance

Supporting Links

Documents

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