U.S. FDA advisory meetings through Aug 19

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT.

For more information on the FDA's Advisory Committee meetings, see: here

BLOOD PRODUCTS ADVISORY COMMITTEE

DATE: July 20, 0800/1200 and July 21, 0900/1300

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: William Freas or Pearline Muckelvene, 301-827-0314

On July 20, in the morning, the committee will review proposed strategies to demonstrate the effectiveness of new coral snake antivenoms. In the afternoon, it will discuss alternative clinical and surrogate endpoints for evaluating efficacy of Alpha-1 Proteinase Inhibitor (Human) augmentation therapy in Alpha-1 antitrypsin deficiency. Alpha-1 antitrypsin deficiency is a genetic condition associated with decreased circulating levels of alpha-1 antitrypsin that significantly increases the risk of serious lung disease (i.e. emphysema) in adults.

On July 21, the committee will hear updates on the following topics: The April 30 to May 1, 2009, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; and an overview of the epidemiology and virology of the 2009 A/H1N1 influenza virus and its impact on the U.S. blood system.

The committee will also hear an update on recent public and private hemovigilance efforts, including the pilot hemovigilance module in the National Healthcare Safety Network.

CIRCULATORY SYSTEM DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

DATE: July 22 and 23, 2009, 0800/1200

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: James Swink, 240-276-4050

On July 22, the committee will discuss, make recommendations, and vote on Medtronic Inc's (MDT.N) Humanitarian Device Exemption application for its Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Valve Delivery System for insufficient or leaky heart valves in patients with congenital heart disease.

On July 23, the committee will discuss general questions about adhesion barriers for cardiovascular use, focusing on understanding the target population (pediatric and/or adult) that would benefit from these devices and the development of appropriate endpoints for a clinical trial.

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

DATE: July 23, 0800/1200

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Christine Walsh or Denise Royster, 301-827-0314

The committee will discuss clinical trials to support use of vaccines against the 2009 H1N1 influenza virus.

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

DATE: July 28, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Elaine Ferguson, 301-827-7001

The committee will discuss King Pharmaceuticals Inc's KG.N binodenoson injection, a short-acting coronary vasodilator, for use as an adjunct to noninvasive myocardial perfusion imaging tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease. The drug's brand name is Corvue.

CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE

DATE: July 29, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Elaine Ferguson, 301-827-7001

The committee will discuss supplemental new drug application from Boehringer Ingelheim for telmisartan tablets for the proposed indication of reduction in the risk of myocardial infarction, stroke, death from cardiovascular causes, or hospitalization for congestive heart failure in patients 55 years or older who are at high risk of developing major cardiovascular events.

PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE

DATE: July 30, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Cicely Reese, 301-827-7001

The committee will discuss the safety and efficacy of Schering-Plough's SGP.N Saphris for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes of bipolar I disorder in adults. The drug's generic name is asenapine.

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY

DATE: Aug. 4, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Janie Kim, 301-827-7001

The committee will discuss bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products.

ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE AND CLINICAL PHARMACOLOGY

DATE: Aug. 5, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Paul Tran, 301-827-7001

The committee will receive an update from the Office of Generic Drugs on bioequivalence for highly variable drugs (highly variable means that the rate and amount of the drug entering blood varies significantly from one administration to another). The committee also will hear presentations from the Office of Pharmaceutical Science (OPS) on the scientific and regulatory challenges of Transdermal Drug Delivery Systems, receive presentations from OPS and discuss current thinking on Classifying Pre-Surgical Preparations as Sterile Products in consideration of how these products are used, and be updated by OPS on the current status of the International Conference on Harmonization (ICH) Quality Topics [i.e., those relating to chemical and pharmaceutical quality assurance (stability testing, impurity testing, etc.)], and outline the role of the ICH Implementation Work Group, its future activities, and any remaining gaps and challenges.

PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE

DATE: Aug. 11, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

The committee will discuss GE HealthCare's experimental radiopharmaceutical for use with a special type of brain imaging in patients with movement disorders. The product, called ioflupane I 123 injection with the proposed brand name DaTSCAN, aims to detect loss of functional nigrostriatal dopaminergic neurons by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs of dopaminergic neurodegeneration. GE Healthcare is a unit of General Electric Co (GE.N).

ADVISORY COMMITTEE FOR REPRODUCTIVE HEALTH DRUGS

DATE: Aug 13, 0800/1200

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Kalyani Bhatt, 301-827-7001

The committee will discuss new biologics license applications from Amgen Inc (AMGN.O) for denosumab subcutaneous injection, 60 milligrams, for the proposed indications of the treatment and prevention of osteoporosis in postmenopausal women, and the treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer. Hormone ablation is a term used to encompass therapies for hormone sensitive breast or prostate cancer administered to decrease sex hormone (estrogen or testosterone) levels. These therapies can result in increased bone loss. The drug's proposed trade name is Prolia.

RISK COMMUNICATION ADVISORY COMMITTEE

DATE: Aug 13-14, 0800/1200

LOCATION: National Transportation Safety Board Conference Center, 429 L'Enfant Plaza SW, Washington

CONTACT: Lee Zwanziger, 301-827-2895

On August 13 and 14, the committee will discuss FDA's external research on, and internal assessment of, communications about food safety problems. This discussion will address research on consumer knowledge of food recalls and plans for how to monitor communication effectiveness during the course of a recall. The purpose of the discussion is to advise FDA on developing more effective communication strategies.

Also on August 14, the committee will be briefed on the work of the FDA Transparency Task Force.

ORTHOPAEDIC AND REHABILITATION DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

DATE: Aug. 18 and 19, 0800/1200

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Ronald Jean, 240-276-3676

On Aug. 18, the committee will weigh DePuy Orthopaedics' Complete Acetabular Hip System, a device system intended for use as a primary joint replacement prosthesis in total hip arthroplasty. The system is indicated for skeletally mature patients suffering severe pain and disability due to structural damage in the hip joint from non-inflammatory degenerative joint disease and its composite diagnoses of osteoarthritis or post-traumatic arthritis. DePuy is a unit of Johnson & Johnson (JNJ.N).

On Aug. 19, the committee will weigh Q-Med AB's QMED.ST Durolane, a device indicated for the treatment of pain caused by osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy and simple analgesics such as acetaminophen. (Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)