federal_register: 2010-29522

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2010-29522 Oncologic Drugs Advisory Committee; Amendment of Notice Notice The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of October 19, 2010 (75 FR 64314). The amendment is being made to reflect changes in the Date and Time, Agenda, and Procedure portions of the document. We also are postponing a session regarding biologics license application (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured by Bristol-Myers Squibb Co. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. This portion of the meeting has been postponed due to the need to complete the review of additional data submitted by the applicant. Future meeting dates may be announced in the Federal Register. 2010-11-23 2010 11 https://www.federalregister.gov/documents/2010/11/23/2010-29522/oncologic-drugs-advisory-committee-amendment-of-notice https://www.govinfo.gov/content/pkg/FR-2010-11-23/pdf/2010-29522.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of October 19, 2010 (75 FR 64314). The amendment is being made to...  

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