Cellular, Tissue and Gene Therapies Advisory Committee
Committee Meeting on June 29, 2011, from 8 a.m. to 5 p.m.
Agenda: On June 29, 2011, the committee will discuss cellular and gene therapy products for the treatment of retinal disorders. Topics to be considered include the following: (1) Efficacy endpoints in pediatric and adult populations, (2) potential safety issues related to repeat administration or second eye administration, and (3) evaluation of product delivery into target site.
Tuesday, May 24, 2011
Microbiology Devices Panel of the Medical Devices Advisory Committee
Microbiology Devices Panel of the Medical Devices Advisory Committee
Committee Meeting on June 29, 2011, from 8 a.m. to 6 p.m.
Agenda: On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification.
Committee Meeting on June 29, 2011, from 8 a.m. to 6 p.m.
Agenda: On June 29, 2011, the committee will discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and the detection of genetic mutations which confer antibiotic resistance in M. tuberculosis complex. Discussion would include the appropriate information and acceptable performance characteristics that would be required to assess the safety and effectiveness of rapid diagnostic tests for M. tuberculosis complex, and whether these can be sufficiently specified to support possible reclassification.
Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing
Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing
Committee Meeting on June 28 and 29, 2011, from 8 a.m. to 5 p.m.
Agenda: The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research''s (CDER''s) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin.
Committee Meeting on June 28 and 29, 2011, from 8 a.m. to 5 p.m.
Agenda: The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research''s (CDER''s) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin.
Pulmonary-Allergy Drugs Advisory Committee
Pulmonary-Allergy Drugs Advisory Committee
Committee Meeting on June 23, 2011, from 8:30 a.m. to 5 p.m.
Agenda: On June 23, 2011, the committee will discuss the new drug application (NDA) 22150, icatibant solution for injection (proposed trade name Firazyr), Shire Human Genetic Therapies, for the proposed indication of treatment of acute attacks of hereditary angioedema.
Committee Meeting on June 23, 2011, from 8:30 a.m. to 5 p.m.
Agenda: On June 23, 2011, the committee will discuss the new drug application (NDA) 22150, icatibant solution for injection (proposed trade name Firazyr), Shire Human Genetic Therapies, for the proposed indication of treatment of acute attacks of hereditary angioedema.
Arthritis Advisory Committee
Arthritis Advisory Committee
Committee Meeting on June 21, 2011, from 8:30 a.m. to 4 p.m.
Agenda: On June 21, 2011, the committee will discuss the supplemental biologics license application 125319, ILARIS (canakinumab), Novartis Pharmaceuticals Corp., for the following proposed indication: ‘‘ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency of subsequent attacks.’’
Committee Meeting on June 21, 2011, from 8:30 a.m. to 4 p.m.
Agenda: On June 21, 2011, the committee will discuss the supplemental biologics license application 125319, ILARIS (canakinumab), Novartis Pharmaceuticals Corp., for the following proposed indication: ‘‘ILARIS is indicated for the treatment of gouty arthritis attacks. ILARIS has also been shown to extend the time to the next attack and reduce the frequency of subsequent attacks.’’
Dermatologic and Ophthalmic Drugs Advisory Committee
Dermatologic and Ophthalmic Drugs Advisory Committee
Committee Meeting on June 17, 2011, from 8 a.m. to 4:30 p.m.
Agenda: On June 17, 2011, the committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed trade name EYLEA, sponsored by Regeneron Pharmaceuticals, Inc., indicated for the treatment of neovascular age-related macular degeneration (wet AMD)
Committee Meeting on June 17, 2011, from 8 a.m. to 4:30 p.m.
Agenda: On June 17, 2011, the committee will discuss biologics license application (BLA) 125387, aflibercept ophthalmic solution, proposed trade name EYLEA, sponsored by Regeneron Pharmaceuticals, Inc., indicated for the treatment of neovascular age-related macular degeneration (wet AMD)
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