FDA announced, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.
H1N1 Flu Fraud Widget (Oct 19)
FDA enhanced its efforts to warn the public about potentially deceptive H1N1 influenza products and to report suspected criminal activity with the release of an H1N1 flu fraud widget. The portable application, embedded in a Web page that can be copied onto any other Web site or blog, will allow the public to play an active role in preventing flu fraud.
Consumers are urged to report any suspected fraudulent products or criminal activity relating to FDA-regulated products associated with H1N1 influenza virus, including the names of Web sites that may be offering these products for sale, to the FDA by visiting: http://www.accessdata.fda.gov/scripts/email/oc/oci/flucontact.cfm
FDA, FTC Issue Joint Warning Letter to Web Site Offering Fraudulent H1N1 Flu Supplements (Oct 15)
FDA and the Federal Trade Commission (FTC) issued a joint warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the 2009 H1N1 influenza virus. The warning letter, the first to be issued jointly by the agencies, advises the owners of the site that they must discontinue the fraudulent marketing of their product or face legal action. The letter further advises the owners of the site that they have 48 hours to give the agencies a plan to discontinue their fraudulent marketing.
FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet (Oct 15)
FDA warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients.
For additional medical product safety information, visit MedWatch: The FDA Safety Information and Adverse Event Reporting Program
PRODUCT APPROVALS:
FDA Approves New Treatment for Chronic Lymphocytic Leukemia (Oct 26)
FDA approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow. Arzerra is approved for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy.
FDA Approves New Treatment for Advanced Form of Kidney Cancer (Oct 19)
FDA approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005. Votrient is an oral medication intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney.
FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use (Oct 19)
FDA approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older. Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.
FDA Approves New Vaccine for Prevention of Cervical Cancer (Oct 16)
The FDA approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The vaccine is approved for use in girls and women ages 10 years through 25 years.
FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys (Oct 16)
FDA approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.
For more information on product approvals, please visit Approvals of FDA-Regulated Products.
ANNOUNCEMENTS:
FDA Announces Plans for LASIK Quality of Life Project (Oct 15)
FDA announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea. The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.
New FDA Web Page Lists Disposal Instructions for Select Medicines (Oct 14)
FDA launched a Web page for consumers with information on how to dispose of certain drugs, including several high-potency opioids and other selected controlled substances.
OPPORTUNITIES FOR COMMENT:
Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs—Public Docket Reopens
On October 19, FDA announced in the Federal Register that the docket for Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs is reopening until October 19, 2010. FDA is reopening the comment period in light of continued public interest in this topic and to provide an opportunity for all interested parties to provide information and share views on this matter.
Transparency Task Force Re-opens Public Docket for More Comments
On August 18, FDA announced in the Federal Register that the docket for the transparency task force is re-opening for more comments until November 6, 2009. Federal Register Notice
Educating the Public About Removal of Essential-Use Designation for Epinephrine
OTC epinephrine metered-dose inhalers are FDA-approved for the temporary relief of shortness of breath, tightness in the chest, and wheezing due to asthma. But the medicine in these inhalers is currently propelled by gases known as chlorofluorocarbons (CFCs). CFCs are harmful to the environment because they decrease the protective ozone layer above the Earth. In order to comply with an international agreement, the Montreal Protocol on Substances that Deplete the Ozone Layer, CFC-propelled epinephrine OTC inhalers cannot be made or sold in the United States after December 31, 2011. Written or electronic comments must be submitted by November 24, 2009. The FDA has established public docket FDA-2009-N-0374
Providing Effective Information to Consumers about Prescription Drug Risks and Benefits; Request for Comments
The FDA has established public docket FDA-2009-N-0295 to receive public comment on potential approaches that will result in written prescription drug information for consumers that is comprehensible, accurate, and easy to access. The docket is open to receive comments until November 25, 2009.
Submit electronic comments to Regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
UPCOMING MEETINGS:
FDA Pediatric Clinical Trials Workshop
DATE: October 29-30, 2009
TIME: 8:00 am – 5:30 pm (Oct 29) and 8:00 am – 12:00 noon (Oct 30)
LOCATION: Holiday Inn College Park, 10000 Baltimore Ave, College Park, MD 20740
CONTACT: Barbara Buch, MD, Phone: 301-796-6384, E-mail: Barbara.buch@fda.hhs.gov
This public workshop is intended to solicit information about and gain perspective from health care providers, academia, and industry on various aspects of clinical trials involving pediatric diseases and patients.
Orthopaedic and Rehabilitation Devices Panel Meeting Announcement
DATE: November 4, 2009
TIME: 8:00 am to 5:00 pm
LOCATION: Holiday Inn, Walker/Whetstone Room, Two Montgomery Village
Ave., Gaithersburg, MD
CONTACT: Ronald P. Jean, 301–796–5650
The committee will discuss, make recommendations and vote on a premarket approval application for the Dynesys Spinal System, sponsored by Zimmer Spine. The Dynesys Spinal System is indicated to provide spinal alignment and stabilization in skeletally
mature patients at one or two contiguous levels from L1–S1.
Risk Communication Advisory Committee Meeting Announcement
DATE: November 12-13, 2009
TIME: 8:00 am – 5:00 pm (Nov 12) and 8:00 am – 2:00 pm (Nov 13)
LOCATION: The Hilton Hotel, 8727 Colesville Road, Silver Spring, M.D. 20910
The Committee will discuss strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products.
Blood Products Advisory Committee Meeting Announcement
DATE: November 16-17, 2009
TIME: 8:00 am – 5:30 pm (Nov 16) and 8:00 am – 5:00 pm (Nov 17)
LOCATION: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814
On November 16, 2009, in the morning the Committee will hear updates on the following topics: the HHS Advisory Committee on Blood Safety and Availability, Dengue virus outbreak, and 2009 A/H1N1 Pandemic and the impact on blood safety and availability. The Committee will then discuss blood donor deferral for malaria risk associated with travel to Mexico. In the afternoon the Committee will discuss the design of a new phase III study of pathogen inactivation of human platelets using the Cerus, INTERCEPT Blood System.
On November 17, 2009, in the morning the Committee will discuss blood pressure and pulse as blood donor eligibility criteria, and in the afternoon the committee will discuss the public health need and performance characteristics of over-the-counter home-use HIV test kits.
FDA Clinical Investigator Training Course
DATE: November 16-18, 2009
TIME: 8:00 am – 5:00 pm (Nov 16 & 17) and 8:00 am – 3:30 pm (Nov 18)
LOCATION: National Labor College, 10000 New Hampshire Avenue, Silver Spring, Maryland 20903.
The first FDA Clinical Investigator Training Course, co-sponsored by FDA’s Office of Critical Path Programs and the Clinical Trials Transformation Initiative, with support from the NIH, is open for registration. This intensive, three-day course will enable clinical investigators to gain a greater appreciation of the scientific, ethical, and regulatory issues relating to clinical trial data that may be submitted to regulatory bodies. Attendees will have the unique opportunity of hearing directly from FDA’s nationally renowned experts on issues critical to successful clinical research. Information on Registration
Radiological Devices Advisory Committee Meeting
DATE: November 17-18, 2009
TIME: 8:00 am – 5:30 pm
LOCATION: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, Maryland.
CONTACT: Toby Lowe, Phone: 301–796–6512
On November 17, 2009, the committee will discuss and make
recommendations regarding the agency’s regulatory strategy for Full Field
Digital Mammography (FFDM) Devices. The committee will discuss the public
comments received in response to the publication of the draft guidance
document entitled ‘‘Class II Special Controls Guidance Document: Full Field
Digital Mammography System.’’
On November 18, 2009, the committee will discuss and make
recommendations regarding the agency’s regulatory strategy for computer assisted
detection (CADe) devices for radiological devices.
Vaccines and Related Biological Products Advisory Committee
DATE: November 18 and 19, 2009
TIME: 8:00 am – 5:45 pm (Nov 18)
8:00 am – 3:15 pm (Nov 19)
LOCATION: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814
CONTACT: Toby Lowe, Phone: 301–796–6512
On November 18, 2009, the committee will discuss and make recommendations on the safety and effectiveness of a Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), BLA125324, and will hear an update on FDA’s Influenza A (H1N1) 2009 monovalent vaccine activities; Post-marketing surveillance.
On November 19, 2009, the committee will discuss and make recommendations on the safety and effectiveness of an Influenza Vaccine, Purified Recombinant Influenza Hemagglutinin, BLA STN125285.
Pulmonary-Allergy Drugs Advisory Committee Meeting
DATE: November 18-20, 2009
TIME: 8:00 am – 5:00 pm
LOCATION: Hilton Washington DC North/Silver Spring, MD, The Ballrooms
8727 Colesville Road, Silver Spring, Maryland
CONTACT: Kristine T. Khuc, Phone: 301-827-7001; E-mail: Kristine.Khuc@fda.hhs.gov
On November 18, 2009, the Committee will discuss BLA # 103976, Supplement # 5149 for Xolair (omalizumab). The proposed indication for this product is to treat moderate to severe persistent asthma in patients between 6 and 11 years of age whose symptoms are inadequately controlled with inhaled steroid medications and have (a) a positive reaction to skin testing with common substances that can cause allergies and asthma, such as pollen, or (b) in vitro reactivity, which is measured with a blood test that confirms the presence of specific proteins consistent with allergies and asthma.
On November 19, 2009, the Committee will discuss the efficacy supplement for NDA 21-395 for the approved product Spiriva HandiHaler (tiotropium inhalation powder), for the reduction in exacerbations in patients with COPD.
On November 20, 2009, the committee will discuss the new drug application (NDA) #22-368 for Aridol (mannitol bronchial challenge test), manufactured by Pharmaxis Ltd. The proposed use of this product is to assess bronchial hyperresponsiveness (airway irritability in the lungs) to aid in diagnosing patients 6 years of age or older who have symptoms of asthma or symptoms that are suggestive of asthma.
Cardiovascular and Renal Drugs Advisory Committee Meeting
DATE: December 7, 2009
TIME: 8:00 am – 5:00 pm
LOCATION: Hilton Washington DC North/Gaithersburg, MD
620 Perry Parkway, Gaithersburg, Maryland
CONTACT: Elaine Ferguson, Phone: 301-827-7001;
E-mail: Elaine.Ferguson@fda.hhs.gov
The committee will discuss new drug application (NDA) 21-560, for everolimus oral tablets, by Novartis Pharmaceuticals Corporation, to be used in patients with kidney transplants to prevent rejection of the transplanted kidney.
DATE: December 8, 2009
TIME: 8:00 am – 5:00 pm
LOCATION: Hilton Washington DC North/Gaithersburg, MD
620 Perry Parkway, Gaithersburg, Maryland
CONTACT: Elaine Ferguson, Phone: 301-827-7001;
E-mail: Elaine.Ferguson@fda.hhs.gov
The committees will discuss safety considerations related to FDA approved gadolinium-based contrast agents used with magnetic resonance imaging (MRI) scans.
Anti-Infective Drugs Advisory Committee Meeting
DATE: December 9 and 10, 2009
TIME: 8:00 am – 5:00 pm
LOCATION: Hilton Washington DC North/Gaithersburg MD
The Ballrooms, 620 Perry Parkway, Gaithersburg, Maryland
CONTACT: Minh Doan, Phone: 301-827-7001; E-mail: minh.doan@fda.hhs.gov
On December 9, 2009, the committee will discuss endpoints and other clinical trial design issues in the development of antibacterial products for the treatment of community-acquired bacterial pneumonia.
On December 10, 2009, the committee will discuss new drug application (NDA) 050–814, inhaled aztreonam, Gilead Sciences, Inc., for the proposed indication of improvement of respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa, a bacterial infection.
Endocrinologic and Metabolic Drugs Advisory Committee Meeting
DATE: December 15, 2009
TIME: 8:00 am – 5:00 pm
LOCATION: Hilton Washington DC North/Gaithersburg MD
The Ballrooms, 620 Perry Parkway, Gaithersburg, Maryland
CONTACT: Paul Tran, Phone: 301-827-7001; E-mail: paul.tran@fda.hhs.gov
The committee will discuss supplemental new drug application (sNDA) 21-366, CRESTOR (rosuvastatin calcium) tablets, AstraZeneca Pharmaceuticals. The proposed indication (use) of CRESTOR in this application is primary prevention of cardiovascular disease based on the results of the JUPITER clinical trial.
Pediatric Oncology Subcommittee Advisory Committee Meeting
DATE: December 15, 2009
TIME: 8:00 am – 5:00 pm
LOCATION: Hilton Washington DC North/Gaithersburg MD
Montgomery Ballroom, 620 Perry Parkway, Gaithersburg, Maryland
CONTACT: Diem-Kieu Ngo, Phone: 301-827-7001; E-mail: diem.ngo@fda.hhs.gov
The subcommittee will consider and discuss: (1) FDA expectations regarding the development of pediatric formulations for cancer drugs, and (2) the development of dosing regimens in infants and toddlers with cancer.
Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results.
If you have any questions, you may contact me at the email listed below.
Best regards,
Beth F. Fritsch, RPh, MBA
Office of Special Health Issues
U.S. Food and Drug Administration
Beth.Fritsch@fda.hhs.gov