8 May 2025
💊FDA Oncologic Drugs Advisory Committee Meeting Notice
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 761309/S-001, for COLUMVI (glofitamab) Injection; Supplemental Biologics License Application 761145/S-029, for DARZALEX FASPRO (daratumumab and hyaluronidase) Injection; New Drug Application 215793, for (mitomycin) Intravesical Solution; Supplemental New Drug Application 211651/S-013, for TALZENNA (talazoparib) Capsules
Summary
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The meeting by the FDA's Oncologic Drugs Advisory Committee involves discussions on new and supplemental drug applications, which directly impact regulatory compliance and market authorization. Businesses in the pharmaceuticals sector need to engage with the public comment process and adapt to regulatory decisions made in this context.