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Imprese · 08/05/20251 min di lettura
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
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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.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →