Food and Drug Administration--Upcoming MeetingsThis is an RSS file. You can use it to subscribe to this data in your favourite RSS reader, such as GoogleReader, or to display this data on your own website or blog. Subscribe to this data using MyMedWorm.Subscribe to this data using GoogleReader.Subscribe to this data using Bloglines.Subscribe to this data using MyYahoo.

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Endocrinologic and Metabolic Drugs Advisory Committee (April 1-2)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On April 1 and 2, 2009, two different new drug applications (NDAs), proposed for the treatment of hyperglycemia in adults with type 2 diabetes mellitus will be discussed. On April 1, 2009, the committee will discuss NDA 22-350, saxagliptin tablets, Bristol-Myers Squibb, and on April 2, 2009, the committee will discuss NDA 22-341, liraglutide injection, Novo Nordisk, Inc.
Source: Food and Drug Administration--Upcoming Meetings - March 31, 2009 Category: American Health Source Type: organizations

Meeting of the Allergenic Products Advisory Committee(March 18)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On March 18, 2009, the committee will discuss 1) a proposed change of potency assay for short ragweed pollen and cat allergen extracts from radial immunodiffusion assay to an enzyme-linked immunosorbent assay and 2) structured product labeling. The committee will also receive an update on research programs in the Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA.
Source: Food and Drug Administration--Upcoming Meetings - March 10, 2009 Category: American Health Source Type: organizations

Meeting of the Circulatory System Devices Panel(March 18)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by TherOx, Inc., for the TherOx Aqueous Oxygen System (AO System). The system is intended for use in acute myocardial infarction (AMI) patients, who have undergone successful revascularization less than or equal to 6 hours from symptom onset. These patients are then randomized to AO Therapy or not. The endpoint is reduction in the final size of the infarct. The system draws blood from the patient, hyperoxygenates it with the AO cartridge component of the system, and reinfuses the blood via the infusion catheter directl...
Source: Food and Drug Administration--Upcoming Meetings - March 10, 2009 Category: American Health Source Type: organizations

Meeting of the Cardiovascular and Renal Drugs Advisory Committee (March 19)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss new drug application (NDA) 22-425, dronedarone 400 milligrams oral tablets, Sanofi Aventis, for the proposed indication in patients with a history of, or current atrial fibrillation or atrial flutter, for the reduction of the risk of cardiovascular hospitalization or death.
Source: Food and Drug Administration--Upcoming Meetings - March 10, 2009 Category: American Health Source Type: organizations

Psychopharmacologic Drugs Advisory Committee (April 7-8)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On April 7, 2009, the committee will discuss safety and efficacy issues with new drug application (NDA) 20-644, Serdolect (sertindole) tablets, Lundbeck USA, proposed for the treatment of schizophrenia. On April 8, 2009, the committee will discuss safety and efficacy issues of supplemental new drug applications (sNDAs) 22-047/S-010/S-011/S-012, Seroquel XR (quetiapine maleate), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of major depressive disorder and sNDA 22-047/S-014/S-015, Seroquel XR (quetiapine maleate), Astra Zeneca Pharmaceuticals LP, proposed for the treatment of generalized anxiety disorder. Part...
Source: Food and Drug Administration--Upcoming Meetings - March 10, 2009 Category: American Health Source Type: organizations

FDA Small Pharmaceutical Business Assistance Educational Forum Public Workshop (April 23)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The workshop is to provide information to small pharmaceutical businesses about FDA's premarket requirements; good manufacturing practices; OTC and generic drug issues.
Source: Food and Drug Administration--Upcoming Meetings - March 10, 2009 Category: American Health Source Type: organizations

Risk Communication Advisory Committee (April 30-May 1)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
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.
Source: Food and Drug Administration--Upcoming Meetings - March 10, 2009 Category: American Health Source Type: organizations

Meeting of the Meeting of the Vaccines and Related Biological Products Advisory Committee (February 18-19)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On February 18, 2009, in the morning, the committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2009 - 2010 influenza season, and in the afternoon will discuss the utility of adding a second B strain to current seasonal influenza vaccines. On February 19, 2009, the committee will discuss the conducting of clinical studies of pandemic influenza vaccine in the pediatric population in the absence of an influenza pandemic.
Source: Food and Drug Administration--Upcoming Meetings - February 13, 2009 Category: American Health Source Type: organizations

Meeting of the Arthritis Advisory Committee (March 5)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss biologics license application (BLA) 125293, pegloticase, Savient Pharmaceuticals, Inc., as a therapy for patients with treatment failure gout.
Source: Food and Drug Administration--Upcoming Meetings - February 13, 2009 Category: American Health Source Type: organizations

Meeting of the Cardiovascular and Renal Drugs Advisory Committee(March 18)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss new drug application (NDA) 22-425, dronedarone 400 milligrams oral tablets, Sanofi Aventis, for the proposed indication in patients with a history of, or current atrial fibrillation or atrial flutter, for the reduction of the risk of cardiovascular hospitalization or death.
Source: Food and Drug Administration--Upcoming Meetings - February 13, 2009 Category: American Health Source Type: organizations

Public Meeting: Cytokine Therapies: Novel Approaches for Clinical Indications(March 26-27)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This event is a public, two-day forum that will focus on the clinical use of cytokines and cytokines antagonists as therapeutic agents for the treatment of human diseases, including cancer and autoimmune disorders such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease.
Source: Food and Drug Administration--Upcoming Meetings - February 13, 2009 Category: American Health Source Type: organizations

Public Meeting: Cytokine Therapies: Novel Approaches for Clinical Indications (March 26-27)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This event is a public, two-day forum that will focus on the clinical use of cytokines and cytokines antagonists as therapeutic agents for the treatment of human diseases, including cancer and autoimmune disorders such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease.
Source: Food and Drug Administration--Upcoming Meetings - February 13, 2009 Category: American Health Source Type: organizations

2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference (June 15-19)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The 2009 PDA/FDA Asia Pacific Pharmaceutical Ingredient Supply Chain Conference is jointly sponsored by PDA and the Shanghai Municipal FDA (SHFDA) as a result of a memorandum of understanding signed in September 2008. Conference sessions will be led by regulatory speakers from the US FDA and the SHFDA, and industry speakers from the United States and China. Topics of discussion will include the global regulatory environment and the integrity of the Pharmaceutical Ingredient Supply Chain.
Source: Food and Drug Administration--Upcoming Meetings - January 13, 2009 Category: American Health Source Type: organizations

2009 PDA/FDA Joint Regulatory Conference (September 14-18)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today's leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes. Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance.
Source: Food and Drug Administration--Upcoming Meetings - January 13, 2009 Category: American Health Source Type: organizations

Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (January 30)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss the available safety and efficacy data for all propoxyphene-containing products (including hydrochloric acid (HCl), napsylate salts, and combination drugs) and whether any regulatory action is appropriate.
Source: Food and Drug Administration--Upcoming Meetings - January 9, 2009 Category: American Health Source Type: organizations

Meeting of the Cardiovascular and Renal Drugs Advisory Committee(February 3)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss new drug application (NDA) 22-307, prasugrel hydrochloride film coated oral tablets, 5 milligrams (mg) and 10 mg, Eli Lilly and Company, for the proposed indication for use in acute coronary syndrome.
Source: Food and Drug Administration--Upcoming Meetings - January 9, 2009 Category: American Health Source Type: organizations

Meeting of the Risk Communication Advisory Committee(February 26-27)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On both days there will be a discussion of different types of prescription drug information currently available to patients in the form of Medicating Guides, Patient Package Inserts (PPIs), and Consumer Medication Information (CMI).
Source: Food and Drug Administration--Upcoming Meetings - January 9, 2009 Category: American Health Source Type: organizations

HIGH-THROUGHPUT METHODS FOR DETECTING FOODBORNE PATHOGENS (May 6)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This three-day workshop will feature in-depth presentations and hands-on laboratory sessions on the detection of foodborne pathogens. Experts from FDA, CDC, USDA, AOAC and industry will present case studies and the latest information on a variety of analytical approaches. This workshop is sponsored by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, the U.S. Department Agriculture, AOAC International, York College of the City University of New York, and the Greater Jamaica Development Corporation.
Source: Food and Drug Administration--Upcoming Meetings - December 10, 2008 Category: American Health Source Type: organizations

MEETING OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE (December 16)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss biologics license application (BLA) 125084, trade name ERBITUX (cetuximab), ImClone Systems, Inc., and BLA 125147, trade name VECTIBIX (panitumumab), Amgen, Inc., in the context of K-ras as a predictive and/or prognostic biomarker in oncology drug development.
Source: Food and Drug Administration--Upcoming Meetings - December 10, 2008 Category: American Health Source Type: organizations

Vaccines and Related Biological Products Advisory Committee (November 20)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. The Committee will meet in open session to hear updates of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Center for Biologics Evaluation and Research, FDA. The Committee will also meet in a Closed Session to discuss the intramural research program.
Source: Food and Drug Administration--Upcoming Meetings - November 19, 2008 Category: American Health Source Type: organizations

Antiviral Drugs Advisory Committee (December 2)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will begin with a closed session from 8 a.m. to 10:30 a.m., to permit discussion and review of trade secret and/or confidential information. Following the closed session, from 10:30 a.m. to 5 p.m., the meeting will be open to the public. The committee will discuss the safety and efficacy of new drug application (NDA) 20-725, Creon (pancrelipase delayed-release capsules), Solvay Pharmaceuticals, Inc., for the treatment of exocrine pancreatic insufficiency.
Source: Food and Drug Administration--Upcoming Meetings - November 19, 2008 Category: American Health Source Type: organizations

Immunology Devices Panel (December 3)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss and make recommendations on the premarket notification application for the Fujirebio HE4 EIA kit and associated Risk of Malignancy algorithm (ROMATM) Test. The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The HE4 EIA, used in conjunction with the ARCHITECT CA 125 II assay, creates a predictive probability of epithelial ovarian cancer using a mathematical function referred to as the ROMATM, for use in premenopausal and postmenopausal women presenting with an adnexal mass who have already been referred to an oncologic specialist and are scheduled...
Source: Food and Drug Administration--Upcoming Meetings - November 19, 2008 Category: American Health Source Type: organizations

Anesthesiology and Respiratory Therapy Devices Panel (December 5)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss, make recommendations and vote on a premarket approval application, sponsored by Emphasys Medical Inc., for the Emphasys Zephyr Endobronchial Valve System, which is intended to improve Forced Expiratory Volume in the first second (FEV1) and 6- minute walk test distance in patients with severe heterogeneous emphysema who have received optimal medical management.
Source: Food and Drug Administration--Upcoming Meetings - November 19, 2008 Category: American Health Source Type: organizations

Orthopaedic and Rehabilitation Devices Panel (December 9)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss, make recommendations and vote on a premarket approval application for Synvisc-One, sponsored by Genzyme Corp. This device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
Source: Food and Drug Administration--Upcoming Meetings - November 19, 2008 Category: American Health Source Type: organizations

Dermatologic and Ophthalmic Drugs Advisory Committee (December 5)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss NDA 22-308, besifloxacin ophthalmic solution (Bausch and Lomb), proposed for the treatment of bacterial conjunctivitis and NDA 22-369, bimatoprost ophthalmic solution, 0.03 percent (Allergan) proposed for the treatment of hypotrichosis of the eyelids.
Source: Food and Drug Administration--Upcoming Meetings - October 31, 2008 Category: American Health Source Type: organizations

Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committtee and Pediatric Advisory Committee (December 10-11)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Committees will discuss the benefit risk assessment of long acting beta-2 adrenergic agonists for the treatment of asthma in adults and children.
Source: Food and Drug Administration--Upcoming Meetings - October 31, 2008 Category: American Health Source Type: organizations

Anti-Infective Drugs Advisory Committee (November 18-20)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On November 18, 2008, the committee will discuss the justification of the non-inferiority margin for complicated skin and skin structure infections. On November 19, 2008, the committee will discuss: (1) New Drug Application (NDA) 022-110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection, and (2) NDA 022-153, oritavancin, Targanta Therapeutics Corp., proposed for the treatment of complicated skin and skin structure infection. On November 20, 2008, the committee will discuss NDA 022-269, iclaprim, Arpida AG, prop...
Source: Food and Drug Administration--Upcoming Meetings - October 24, 2008 Category: American Health Source Type: organizations

Circulatory System Devices Panel (November 20)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Biosense Webster, Inc., a Johnson and Johnson Company, for the NaviStar ThermoCool irrigated RF ablation catheter. The device, an open-lumen, irrigated tip, steerable radiofrequency cardiac ablation catheter, is inserted through the venous circulation to the heart, across the intra-atrial septum to the left atrium to ablate cardiac tissue for the purposes of creating lines of block in the atria to eliminate conduction patterns that theoretically generate or allow propagation of paroxysmal atrial fibrillation.
Source: Food and Drug Administration--Upcoming Meetings - October 24, 2008 Category: American Health Source Type: organizations

Arthritis Advisory Committee (November 24)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss new drug application (NDA) 21- 856, ULORIC (febuxostat), Takeda Pharmaceuticals North America, Inc., for the proposed treatment of hyperuricemia in patients with gout.
Source: Food and Drug Administration--Upcoming Meetings - October 24, 2008 Category: American Health Source Type: organizations

Obstetrics and Gynecology Devices Panel (December 11)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss, make recommendations, and vote on a premarket approval application for the FC2 Female Condom, sponsored by the Female Health Company. This device is indicated to help prevent HIV/AIDS and unintended pregnancy.
Source: Food and Drug Administration--Upcoming Meetings - October 24, 2008 Category: American Health Source Type: organizations

Science Board to the Food and Drug Administration (October 31)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Science Board will hear about and discuss a review of the draft assessment of Bisphenol A (BPA) for use in food contact applications by the Science Board BPA Subcommittee. The Science Board will discuss 2009 agenda topics. The Science Board will also hear an overview of current methods for detection of contaminants in FDA-regulated products.
Source: Food and Drug Administration--Upcoming Meetings - October 14, 2008 Category: American Health Source Type: organizations

General and Plastic Surgery Devices Panel (November 18-19)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On November 18, 2008, the committee will receive an update on safety information collected on dermal fillers in the commercial setting, discuss current premarket and postmarket approved study designs, and make recommendations on general issues concerning the study of various dermal fillers. In addition, the committee will discuss the design of clinical trials for future premarket submissions seeking approval of dermal fillers for new intended uses. On November 19, 2008, the committee will discuss and make recommendations on general issues related to the clinical trials of cosmetic devices. Specifically, the committee will ...
Source: Food and Drug Administration--Upcoming Meetings - October 14, 2008 Category: American Health Source Type: organizations

Anti-Infective Drugs Advisory Committee (December 3)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss new drug application (NDA) 22-268, artemether 20 mg/lumefantrine 120mg, sponsored by Novartis Pharmaceuticals Corporation, for the proposed indication of treatment of acute, uncomplicated malaria infection due to Plasmodium falciparum or mixed infections including P. falciparum.
Source: Food and Drug Administration--Upcoming Meetings - October 14, 2008 Category: American Health Source Type: organizations

Cardiovascular and Renal Drugs Advisory Committee (December 10)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will discuss new drug application (NDA) 22-349, IMAGIFY (perflubutane polymer microspheres) injectable suspension, Acusphere Inc., proposed for use as an ultrasound imaging agent indicated for patients with stable chest pain being evaluated for inducible ischemia for the detection of coronary artery disease based on assessment of myocardial perfusion and wall motion.
Source: Food and Drug Administration--Upcoming Meetings - October 14, 2008 Category: American Health Source Type: organizations

Antiviral Drugs Advisory Committee (October 30)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The meeting will be open to the public from 8 a.m. to 9 a.m., unless public participation does not last that long. From 9 a.m. to 1 p.m., the meeting will be closed to permit discussion of current and future advances on antiviral drugs which will include the review of trade secret and/or confidential information.
Source: Food and Drug Administration--Upcoming Meetings - October 7, 2008 Category: American Health Source Type: organizations

Public Meeting on Over-the-Counter Cough and Cold Medications for Pediatric Use (October 2)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On October 2, FDA's Center for Drug Evaluation and Research will convene a public meeting to obtain public comment about over-the-counter cough and cold medications for pediatric use as it proceeds with the rulemaking for these ingredients.
Source: Food and Drug Administration--Upcoming Meetings - September 25, 2008 Category: American Health Source Type: organizations

Public Meeting: Preparation for International Conference on Harmonization (ICH) Meetings (October 21)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Brussels, Belgium, November 10 to 13, at which discussion of the topics underway and the future of ICH will continue.
Source: Food and Drug Administration--Upcoming Meetings - September 25, 2008 Category: American Health Source Type: organizations

Endocrinologic and Metabolic Drugs Advisory Committee (October 21)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On October 21, 2008, the committee will begin with a closed session from 8 a.m. to 11 a.m. Following the closed session, from 11 a.m. to 5 p.m., the meeting will be open to the public. The committee will discuss the safety and efficacy of biologic license application (BLA) 125291, MYOZYME (algucosidase alfa) Genzyme Corporation, for the treatment of late onset Pompe disease.
Source: Food and Drug Administration--Upcoming Meetings - September 25, 2008 Category: American Health Source Type: organizations

Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee (October 29)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The committee will provide advice on types of studies and trial designs needed for an influenza antiviral MedKit for the treatment or prophylaxis of pandemic influenza and discuss publicly the proposed development program that would support an application for such a MedKit. Issues such as the role of personal MedKits, home stockpiling, non-prescription availability of influenza medications, and interfaces of home readiness with public health systems, will be raised in the course of the discussions.
Source: Food and Drug Administration--Upcoming Meetings - September 25, 2008 Category: American Health Source Type: organizations

Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry (November 17)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of the public workshop is to provide the biologics industry with guidance on submitting to FDA content of labeling in SPL format, present an overview of FDA's voluntary pilot program for electronic submission of drug establishment registration and drug listing information under the regulations, and exhibit vendor SPL authoring tools that may be used in the creation and manipulation of SPL content of labeling.
Source: Food and Drug Administration--Upcoming Meetings - September 25, 2008 Category: American Health Source Type: organizations

Peripheral and Central Nervous System Drugs Advisory Committee (October 23)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Committee will discuss the clinical development of radionuclide imaging products for the detection of amyloid to assist in the diagnosis of Alzheimer's Disease.
Source: Food and Drug Administration--Upcoming Meetings - September 8, 2008 Category: American Health Source Type: organizations