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NEUROLOGICAL DEVICES PANEL
DATE: May 14, 2009, 8:00 a.m.
LOCATION: Holiday Inn, Ballroom,
Two Montgomery Village Ave,
Gaithersburg , MD
CONTACT: Peter L. Hudson, Center for Devices and Radiological Health, 240-276-3737. The committee will discuss, make recommendations and vote on a premarket approval application for the DuraSeal Xact™ Sealant System, sponsored by Confluent Surgical Inc. This device is indicated for use as an adjunct to sutured dural repair to obtain watertight closure during spinal surgery. More Information
CELLULAR, TISSUE AND GENE THERAPIES ADVISORY COMMITTEE
DATE: May 14-15, 2009, 8:00 a.m.
LOCATION: Hilton Hotel, Grand Ballroom, 620 Perry Parkway, Gaithersburg, Maryland
CONTACT: Gail Dapolito or Danielle Cubbage,
301-827-0314. On May 14 in the morning, in open session, the Committee will discuss the potential for Chlamydia trachomatis and Neisseria gonorrhea transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps) that are recovered from the reproductive system or gestational tissues (e.g., amnionic membrane and placenta, cells recovered from menstrual blood, foreskin, placental/umbilical cord blood derived cell products), or other sources. In the afternoon, in open session, the Committee will discuss animal models for porcine xenotransplantation products intended to treat Type 1 diabetes or acute liver failure. On May 15, in open session, the Committee will 1) receive an update on Guidance documents from the Office of Cellular, Tissue and Gene Therapies and the Center for Veterinary Medicine, 2) discuss clinical issues related to the FDA draft guidance “Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage.” More Information
SCIENCE BOARD TO THE FOOD AND DRUG ADMINISTRATION
DATE: May 18, 2009, 9:00 a.m.
LOCATION: Hilton Washington DC/Rockville Hilton,
1750 Rockville Pike,
Rockville, MD
CONTACT: Carlos Pena, Ph.D.,
Office of Commissioner,
301-827-3340. The Science Board will hear about and discuss updates from the following subcommittees: (1) The review of each Center’s projects within scientific priority areas, (2) the review of research at the Center for Veterinary Medicine, and (3) the review of FDA’s scientific information technology infrastructure modernization initiatives. The Science Board will also hear updates on rapid detection of Salmonella in foods and the handling of biospecimens used for genomic and proteomic analyses. More Information
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
DATE: May 19, 2009, 8:00 a.m.
LOCATION: Hilton /Silver Spring,
The Ballrooms,
8727 Colesville Road,
Silver Spring, Maryland
CONTACT: Kristine T. Khuc, Pharm.D.,
Center for Drug Evaluation and Research, 301-827-7001.
The committee will discuss the safety and efficacy of (NDA) 21-761, Sanvar,
(vapreotide acetate), by Debiovision, Inc., for the proposed indication as an adjunctive therapy to endoscopic intervention for the control of acute esophageal bleeding as a result of portal hypertension. More Information
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
DATE: May 20, 2009, 8:00 a.m.
LOCATION: Hilton /Silver Spring,
The Ballrooms,
8727 Colesville Road,
Silver Spring, Maryland
CONTACT: Kristine T. Khuc, Pharm.D.,
Center for Drug Evaluation and Research, 301-827-7001. The committee will discuss the safety and efficacy of new drug application (NDA) 22-336 Rezonic (casopitant mesylate) tablets, GlaxoSmithKline, 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). More Information
ANESTHESIOLOGY AND RESPIRATORY THERAPY DEVICES PANEL
DATE: May 28, 2009, 8:00 a.m.
LOCATION: Holiday Inn, Ballroom,
Two Montgomery Village Ave.,
Gaithersburg , MD
CONTACT: Neel J. Patel, Center for Devices and Radiological Health, 240-276-3700. The committee will discuss, make recommendations and vote on a premarket approval application for the SEDASYS™ Computer-Assisted Personalized Sedation System sponsored by Ethicon Endo-Surgery, Inc. The device is indicated for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as identified by the American Society of Anesthesiologists Continuum of Depth of Sedation, in adult patients (American Society of Anesthesiology physical status I, II, or III) undergoing colonoscopy and esophagogastroduodenoscopy procedures. More Information
ONCOLOGIC DRUGS ADVISORY COMMITTEE
DATE: May 29, 2009, 8:00 a.m.
LOCATION: Rosen Shingle Creek,
Panzacola Ballroom,
9939 Universal Boulevard,
Orlando, FL 32819
CONTACT: Nicole Vesely,
Center for Drug Evaluation and Research, 301-827-7001. On May 29, 2009, the committee will discuss the biologics license application (BLA) 125326, proposed trade name Arzerra (ofatumumab), GlaxoSmithKline, for the proposed indication of treatment of patients with chronic lymphocytic leukemia who have received prior therapy. More Information
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: June 2, 8:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring,
The Ballrooms,
8727 Colesville Road
Silver Spring, Maryland
CONTACT: Janie Kim,
Center for Drug Evaluation and Research,
Phone: 301-827-7001.
The committee will discuss new drug application (NDA) 22-398, cethromycin oral tablets, sponsored by Advanced Life Sciences, for the proposed indication of outpatient treatment of adults with mild to moderate community-acquired pneumonia. More Information
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
DATE: June 3, 8:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring,
The Ballrooms,
8727 Colesville Road
Silver Spring, Maryland
CONTACT: Janie Kim,
Center for Drug Evaluation and Research,
Phone: 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. More Information
PUBLIC WORKSHOP: DRUGS AND DEVICES--PROMOTING AND PROTECTING THE PUBLIC HEALTH THROUGH RISK MANAGEMENT AND PRODUCT CYCLE IMPROVEMENT
DATE: June 8-9, 2009
LOCATION: Doubletree Hotel Chicago--Oakbrook, 1909 Spring Rd., Oak Brook, IL 60523.
CONTACT: William Weissinger, Food and Drug Administration, 550 W. Jackson Blvd., 15th Fl., Chicago, IL 60661, 312–596–4210, FAX: 312–596–4242, e-mail: William.weissinger@fda.hhs.gov. The Food and Drug Administration, Chicago District, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled "Drugs and Devices--Promoting and Protecting the Public Health Through Risk Management and Product Cycle Improvement." This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry. Topics include: Risk management approach to consumer protection and industry regulation; How quality management systems (including corrective and preventive action) contribute to product cycle improvement; Supplier management and component controls for drugs and devices; Adverse drug event reporting requirements; Medical device reporting requirements; Recalls, corrections and removals; Complaint handling from the FDA investigator’s perspective. To register, contact AFDO, 717–757–2888, FAX:717–755–8089, or e-mail: afdo@afdo.org. More Information
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
DATE: June 9-10, 2009, 8:00 a.m.
LOCATION: Marriott Conference Centers,
UMUC Inn and Conference Center by Marriott,
3501 University Blvd. East,
Adelphi, Maryland
CONTACT: Diem-Kieu Ngo,
Center for Drug Evaluation and Research, 301-827-7001. The committee will discuss safety and efficacy issues for the following new drug applications (NDA): 1) NDA 20-639/S-045 and S-046: Seroquel (quetiapine), AstraZeneca Pharmaceuticals LP, for (a) the acute treatment of schizophrenia in adolescents (13-17 years of age), and (b) the acute treatment of bipolar mania in children (10-12 years of age) and adolescents (13-17 years of age); 2) NDA 20-825/S-032: Geodon (ziprasidone), Pfizer Inc., for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features in children and adolescents ages 10-17 years; and 3) NDA 20-592/S-040 and S-041: Zyprexa (olanzapine), Eli Lilly and Company, for (a) the acute treatment of manic or mixed episodes associated with bipolar I disorder, and (b) the acute treatment of schizophrenia in adolescents. The committee will be asked to vote on whether or not these products have been shown to be effective and acceptably safe for these pediatric indications. More Information
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES COMMITTEE
DATE: June 12, 8:00 a.m.
LOCATION: Holiday Inn Gaithersburg, Grand Ballroom, 2 Montgomery Village Ave. Gaithersburg, Maryland 20879
CONTACT: William Freas, Ph.D.,
301-827-1295. On June 12, 2009, the Committee will review and discuss a recent report from the UK Health Protection Agency attributing a case of variant Creutzfeldt-Jakob (vCJD) disease infection to treatment 11 years earlier with a “vCJD-implicated” plasma-derived coagulation factor VIII (pdFVIII) and whether this information or any other recent scientific information about the vCJD epidemic substantially alters FDA’s risk assessment for US-licensed preparations of pdFVIII products. In the afternoon the committee will hear informational presentations on animal models of vCJD, diagnostic test development for transmissible spongiform encephalopathies (TSEs) and bovine spongiform encephalopathy (BSE) surveillance and risk management. More Information
2009 PDA/FDA ASIA-PACIFIC PHARMACEUTICAL INGREDIENT
SUPPLY CHAIN CONFERENCE
DATE: June 15-19, 2009
LOCATION: Shanghai, China
CONTACT: Wanda Neal, Vice President, Programs
and Registration Services, neal@pda.org or
+1 (301) 656-5900 ext. 111. 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. More information
JOINT MEETING OF THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE WITH THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE AND THE NONPRESCRIPTION DRUGS ADVISORY COMMITTEE
DATE: June 29-30, 2009, 8:00 a.m.
LOCATION: Marriott Conference Centers,
UMUC Inn and Conference Center by Marriott,
3501 University Blvd. East,
Adelphi, Maryland
CONTACT: Elaine Ferguson,
Center for Drug Evaluation and Research,
301-827-7001. The primary topic area for discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern. More Information
2009 PDA/FDA JOINT REGULATORY CONFERENCE
DATE: September 14-18, 2009
LOCATION: Renaissance Hotel, 999 9th Street
NW, Washington, D.C. 20001
CONTACT: Wanda Neal, Vice President, Programs
and Registration Services, neal@pda.org or
+1 (301) 656-5900 ext. 111. 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. More
Information
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