FDAAdvisoryCommittee.com March 22, 2009 – Oncologic Drugs Advisory Committee Agenda: On March 22, 2010, during the morning session, the committee will discuss new drug application (NDA) 022-481, proposed trade name PIXUVRI (pixantrone dimaleate) injection, manufactured by Cell Therapeutics, Inc. The proposed indication (use) for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive non-Hodgkin’s lymphoma (NHL) who have received two or more prior lines of therapy.
During the afternoon session, the committee will discuss NDA 022-374, proposed trade name OMAPRO (omacetaxine mepesuccinate) for injection, manufactured by ChemGenex Pharmaceuticals. The proposed indication (use) for this product is for the treatment of adults with chronic myeloid leukemia (CML) bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib
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Friday, March 12, 2010
Thursday, March 11, 2010
March 17th Pharmaceutical Science and Clinical Pharmacology AdComm - FDAAC.com
FDAAdvisoryCommittee.com March 17, 2010 – Advisory Committee for Pharmaceutical Science and Clinical Pharmacology Agenda: On March 17, 2010, the committee will discuss and provide comments on the following topics: (1) General scientific issues related to the application of pharmacogenomics in the early stages of drug development. Pharmacogenomics examines the genetic differences that influence a person's responses, both beneficial and harmful, to certain drugs; (2) a new patient-centric clinical pharmacology approach to drug safety; (3) the design and analysis of clinical pharmacology studies focusing on how the renal function changes in the way the body absorbs, distributes, metabolizes, and excretes a drug in patients with kidney impairment; and (4) scientific considerations and recent developments in transporter-mediated drug interactions. These interactions are between two or more drugs that either inhibit or enhance the roles of specialized proteins known as ``transporters'' and, in turn, the interactions can affect a drug's safety and/or efficacy.
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March 18th & 19th Circulatory System Devices AdComm - CRT-Ds (Boston Scientific) & REVO (Medtronic) - FDAAC.com
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March 18 & 19, 2010 - Circulatory System Devices Panel of the Medical Devices Advisory Committee Committee
PMA - CRT-Ds (Boston Scientific)
PMA - REVO MRI Pacemaker System (Medtronic)
Agenda: On March 18, 2010, the committee will discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) sponsored by Boston Scientific. The sponsor is seeking expanded indications for the their CRT-Ds to include patients with low left ventricular ejection fraction (<=30%) and wide QRS (>=130 ms) who are NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I (ischemic etiology).
Agenda: On March 19, 2010, the committee will discuss, make recommendations and vote on a PMA for the REVO MRI Pacemaker System sponsored by Medtronic. The REVO MRI Pacing System is a pacemaker (with a standard pacing indication) that has been specifically designed to be safe for the MRI environment under certain MR scanning conditions.
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