THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL ITEMS ARE EDT/GMT.
For more information on the FDA's Advisory Committee meetings, see: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
(Adds April 12 blood products meeting, April 22 pain drug meeting, May 6 central nervous system drugs committee)
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY
DATE: March 17, 0730/1130
LOCATION: Marriott Marquis, 265 Peachtree Center Ave., Atlanta, Ga.
CONTACT: Yvette Waples, 301-827-7001
The committee will discuss and provide comments on the following topics: general scientific issues related to the application of pharmacogenomics in the early stages of drug development; a new patient-centric clinical pharmacology approach to drug safety; 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 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.
CIRCULATORY SYSTEMS DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: March 18-19, 0800/1200
LOCATION: Holiday Inn, 10000 Baltimore Ave., College Park, Md.
CONTACT: James Swink, 301-796-6313
On March 18, the committee will discuss, make recommendations, and vote on the premarket approval application for Cardiac Resynchronization Therapy Defibrillators (CRTDs) sponsored by Boston Scientific. The sponsor is seeking expanded indications for CRTDs to include patients with low left ventricular ejection fraction and wide QRS who are NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I (ischemic etiology).
On March 19, the committee will discuss, make recommendations and vote on a premarket approval application 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.
PEDIATRIC ADVISORY COMMITTEE
DATE: March 22, 0800/1200
LOCATION: Marriott, 5151 Pooks Hill Road, Bethesda, Md.
CONTACT: Doreen Kezer, 301-827-1249
The committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for L'Oreal sunscreen ingredient Anthelios 40, DuPont imaging agent Cardiolite (technetium Tc-99), Sanofi-Aventis allergy drug Nasacort AQ (triamcinolone), Boehringer Ingelheim HIV drug Viramune (nevirapine), GlaxoSmithKline herpes drug Valtrex (valacyclovir) and rotavirus vaccine Rotarix, Pfizer Incantibiotic Zmax (azithromycin), Glaxo diphtheria, tetanus and pertussis vaccine Kinrix and Sanofi five-disease vaccine Pentacel and diphtheria, tetanus and pertussis vaccine Daptacel.
The committee also will receive an update on topical calcineurin inhibitors for eczema: Novartis AG's Elidel (pimecrolimus) and Astellas Pharma's Protopic (tacrolimus).
The committee also will receive a brief followup on the FDA Early Communication about reports of liver-related adverse events in patients taking orlistat, marketed by Glaxo as Alli and Roche Holding AG as Xenical.
ONCOLOGIC DRUGS ADVISORY COMMITTEE
DATE: March 22, 0800/1200
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Nicole Vesely, 301-827-6793
During the morning session, the committee will discuss a new drug application from Cell Therapeutics Inc for a drug with the proposed brand name Pixuvri (pixantrone). The proposed use for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive Non-Hodgkin's Lymphoma who have received two or more prior lines of therapy.
During the afternoon session, the committee will discuss a new drug application from ChemGenex Pharmaceuticals for a drug with the proposed trade name Omapro (omacetaxine mepesuccinate) for injection. The proposed use for this product is for the treatment of adults with chronic myeloid leukemia bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib. Keywords: FDA ADVISORY/DIARY
COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
For more information on the FDA's Advisory Committee meetings, see: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
(Adds April 12 blood products meeting, April 22 pain drug meeting, May 6 central nervous system drugs committee)
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY
DATE: March 17, 0730/1130
LOCATION: Marriott Marquis, 265 Peachtree Center Ave., Atlanta, Ga.
CONTACT: Yvette Waples, 301-827-7001
The committee will discuss and provide comments on the following topics: general scientific issues related to the application of pharmacogenomics in the early stages of drug development; a new patient-centric clinical pharmacology approach to drug safety; 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 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.
CIRCULATORY SYSTEMS DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE
DATE: March 18-19, 0800/1200
LOCATION: Holiday Inn, 10000 Baltimore Ave., College Park, Md.
CONTACT: James Swink, 301-796-6313
On March 18, the committee will discuss, make recommendations, and vote on the premarket approval application for Cardiac Resynchronization Therapy Defibrillators (CRTDs) sponsored by Boston Scientific. The sponsor is seeking expanded indications for CRTDs to include patients with low left ventricular ejection fraction and wide QRS who are NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I (ischemic etiology).
On March 19, the committee will discuss, make recommendations and vote on a premarket approval application 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.
PEDIATRIC ADVISORY COMMITTEE
DATE: March 22, 0800/1200
LOCATION: Marriott, 5151 Pooks Hill Road, Bethesda, Md.
CONTACT: Doreen Kezer, 301-827-1249
The committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for L'Oreal sunscreen ingredient Anthelios 40, DuPont imaging agent Cardiolite (technetium Tc-99), Sanofi-Aventis allergy drug Nasacort AQ (triamcinolone), Boehringer Ingelheim HIV drug Viramune (nevirapine), GlaxoSmithKline herpes drug Valtrex (valacyclovir) and rotavirus vaccine Rotarix, Pfizer Incantibiotic Zmax (azithromycin), Glaxo diphtheria, tetanus and pertussis vaccine Kinrix and Sanofi five-disease vaccine Pentacel and diphtheria, tetanus and pertussis vaccine Daptacel.
The committee also will receive an update on topical calcineurin inhibitors for eczema: Novartis AG's Elidel (pimecrolimus) and Astellas Pharma's Protopic (tacrolimus).
The committee also will receive a brief followup on the FDA Early Communication about reports of liver-related adverse events in patients taking orlistat, marketed by Glaxo as Alli and Roche Holding AG as Xenical.
ONCOLOGIC DRUGS ADVISORY COMMITTEE
DATE: March 22, 0800/1200
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: Nicole Vesely, 301-827-6793
During the morning session, the committee will discuss a new drug application from Cell Therapeutics Inc for a drug with the proposed brand name Pixuvri (pixantrone). The proposed use for this product is as a single agent treatment for patients with recurring or refractory (difficult to treat), aggressive Non-Hodgkin's Lymphoma who have received two or more prior lines of therapy.
During the afternoon session, the committee will discuss a new drug application from ChemGenex Pharmaceuticals for a drug with the proposed trade name Omapro (omacetaxine mepesuccinate) for injection. The proposed use for this product is for the treatment of adults with chronic myeloid leukemia bearing a genetic alteration known as the Bcr-Abl T315I mutation, and who have failed prior therapy with the drug imatinib. Keywords: FDA ADVISORY/DIARY
COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2010 AFX News
