Monday April 6, 04:08 PM
U.S. FDA advisory meetings through June 3
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT.
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
DATE: April 7-8, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Yvette Waples, 301-827-7001
On April 7, the committee will discuss safety and efficacy issues of a new drug application from Lundbeck USA for Serdolec tablets proposed for the treatment of schizophrenia.
On April 8, the committee will discuss safety and efficacy issues of supplemental new drug applications from AstraZeneca Plc for Seroquel XR for the treatment of major depressive disorder and generalized anxiety disorder. Particular safety issues for discussion on April 8, regarding the Seroquel XR applications are concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia.
CIRCULATORY SYSTEM DEVICES PANEL
DATE: April 23, 0830/1230
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: James Swink, 240-276-4050
The committee will discuss, make recommendations and vote on a premarket approval application from privately held Atritech Inc for the Watchman Left Atrial Appendage (LAA) Closure Technology. The Watchman device, a percutaneously placed permanent implant, is intended as an alternative to warfarin therapy for patients with non-valvular atrial fibrillation. The Watchman LAA Closure Technology is designed to prevent embolization of thrombi that may form in the left atrial appendage thereby preventing the occurrence of ischemic stroke and systemic thromboembolism.
RISK COMMUNICATION ADVISORY COMMITTEE
DATE: April 30 and May 1, 0800/1200
LOCATION: Food and Drug Administration, 5630 Fishers Lane, Rockville, Md.
CONTACT: Lee Zwanziger, (301) 827-2895
On both days the committee will discuss the agency's draft risk communication strategic plan and will be asked for comment and further advice, for example, on strategic priorities for research on effective risk communication.
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
DATE: May 19, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committee will discuss the safety and efficacy of a new drug application from Debiovision Inc for Sanvar for the proposed indication as an adjunctive therapy to endoscopic intervention for the control of acute esophageal bleeding as a result of portal hypertension. Salix Pharmaceuticals (NASDAQ: SLXP - news) holds U.S. marketing rights for Sanvar.
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
DATE: May 20, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Kristine Khuc, 301-827-7001
The committee will discuss the safety and efficacy of a new drug application from GlaxoSmithKline PLC (LSE: GSK.L - news) for Rezonic tablets in combination with other antiemetic agents for the proposed indications of prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy (HEC), prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC), and prevention of postoperative nausea and vomiting (PONV).
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: June 2, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Janie Kim, 301-827-7001
The committee will discuss new drug application from Advanced Life Sciences (ADLS - news) for cethromycin oral tablets for the proposed indication of outpatient treatment of adults with mild to moderate community-acquired pneumonia.
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: June 3, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Janie Kim, 301-827-7001
The committee will discuss issues related to the development of drugs for the treatment of tuberculosis, including drug resistant tuberculosis. Areas of discussion include diagnosis, treatment duration, study design (such as endpoints and duration of follow-up) and safety issues.
(Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn) Keywords: FDA ADVISORY/DIARY
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