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FDA
Open for Comments
FDA-2026-P-6789
Requests that the FDA review whether the two primary generic bicalutamide tablet suppliers can assure the safety, efficacy, and quality of bicalutamide tablets for the intended prostate cancer patient population.
Documents
2
Comments
0
Key Dates
Comment Period OpensJun 15, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
Buchanan Ingersoll and Rooney PC
Review whether the two primary
generic bicalutamide tablet suppliers
both of which are under significant regulatory
scrutiny can assure the safety efficacy
and quality of bicalutamide tablets for the
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