U.S. Food and Drug Administration
Office of Special Health Issues 10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone (Sept 26)http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm
FDA is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills.
FDA Drug Safety Communication: Abnormal heart rhythms may be associated with use of Zofran (ondansetron) (Sept 15)
http://www.fda.gov/Drugs/DrugSafety/ucm271913.htmFDA is informing the public of an ongoing safety review of the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and their generics). Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch
PRODUCT APPROVALS:
FDA approves Remicade to treat ulcerative colitis in children 6 years and older (Sept 23)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm272997.htm
FDA approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children 6 years and older who have had inadequate response to conventional therapy.
FDA approves Soliris for rare pediatric blood disorder (Sept 23)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm272990.htmFDA approved Soliris (eculizumab) to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.
For information on drug approvals, please visit Drugs@FDA
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
MedWatch: The Food and Drug Administration Medical Products Reporting Program
http://www.gpo.gov/fdsys/pkg/FR-2011-09-09/pdf/2011-23094.pdfThis notice solicits comments on revisions to Form FDA 3500 and Form FDA 3500A, and proposed consumer version of Form FDA 3500 (known as the MedWatch reporting form) used in the FDA Medical Products Reporting Program. Comments due November 8, 2011
Approaches to Reducing Sodium Consumption; Establishment of Dockets; Request for Comments, Data, and Information
http://www.gpo.gov/fdsys/pkg/FR-2011-09-15/pdf/2011-23753.pdf
FDA and the Food Safety and Inspection Service are announcing the establishment of dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium as well as current and emerging approaches designed to promote sodium reduction.Submit either electronic or written comments and data and information by November 29, 2011.
Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms; Extension of Comment Period
http://www.gpo.gov/fdsys/pkg/FR-2011-09-14/pdf/2011-23479.pdfFDA is extending the comment period for the advance notice of proposed rulemaking that published on June 17, 2011. The ANPRM is requesting data and information on certain dosage forms of over-the-counter sunscreen drug products marketed without approved applications. Comments due October 17, 2011.
Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products
http://www.gpo.gov/fdsys/pkg/FR-2011-09-09/pdf/2011-23096.pdfFDA is requesting comments, data, research, or other information related to non-face-to-face sale and distribution of tobacco products; the advertising, promotion, and marketing of such products; and the advertising of tobacco products via the Internet, e-mail, direct mail, telephone, smart phones, and other communication technologies that can be directed to specific recipients. Comments due November 8, 2011.
Draft Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
http://www.gpo.gov/fdsys/pkg/FR-2011-08-30/pdf/2011-22146.pdf
This draft guidance provides recommendations to sponsors of new drug applications and abbreviated new drug applications regarding what criteria should be met to facilitate the evaluation and labeling of tablets that have been scored. Although you can comment on any guidance at any time, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 28, 2011.
Food Labeling; Gluten-Free Labeling of Foods; Reopening of the Comment Period
http://www.gpo.gov/fdsys/pkg/FR-2011-08-03/pdf/2011-19620.pdf%20
FDA encourages members of the food industry, state and local governments, consumers, and other interested parties to offer comments and suggestions about gluten-free labeling in docket number FDA-2005-N-0404. Comments due October 3, 2011.
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Request for Comments
http://www.gpo.gov/fdsys/pkg/FR-2011-08-12/pdf/2011-20502.pdf
FDA is requesting comments, including scientific and other information, concerning the harmful and potentially harmful constituents in tobacco products and tobacco smoke. Comments due October 11, 2011.
Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the Comment Period
http://links.govdelivery.com/track?type=click&enid=bWFpbGluZ2lkPTIwMTEwOTI4LjMxMzU5NDEmbWVzc2FnZWlkPU1EQi1QUkQtQlVMLTIwMTEwOTI4LjMxMzU5NDEmZGF0YWJhc2VpZD0xMDAxJnNlcmlhbD0xMjc3MDczNjE0JmVtYWlsaWQ9Y2VyYXNhbGUzMTRAZ21haWwuY29tJnVzZXJpZD1jZXJhc2FsZTMxNEBnbWFpbC5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&113&&&http://www.gpo.gov/fdsys/pkg/FR-2011-08-11/pdf/2011-20406.pdfFDA is reopening the comment period for the proposed rule published in the Federal Register of December 8, 2010, proposing to amend regulations on plant sterol/stanol esters and risk of coronary heart disease. Comments due October 25, 2011.
Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability
http://links.govdelivery.com/track?type=click&enid=bWFpbGluZ2lkPTIwMTEwOTI4LjMxMzU5NDEmbWVzc2FnZWlkPU1EQi1QUkQtQlVMLTIwMTEwOTI4LjMxMzU5NDEmZGF0YWJhc2VpZD0xMDAxJnNlcmlhbD0xMjc3MDczNjE0JmVtYWlsaWQ9Y2VyYXNhbGUzMTRAZ21haWwuY29tJnVzZXJpZD1jZXJhc2FsZTMxNEBnbWFpbC5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&114&&&http://www.gpo.gov/fdsys/pkg/FR-2011-08-15/pdf/2011-20603.pdfThis guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in effect at this time. Comments due November 14, 2011.
Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review; Availability
http://links.govdelivery.com/track?type=click&enid=bWFpbGluZ2lkPTIwMTEwOTI4LjMxMzU5NDEmbWVzc2FnZWlkPU1EQi1QUkQtQlVMLTIwMTEwOTI4LjMxMzU5NDEmZGF0YWJhc2VpZD0xMDAxJnNlcmlhbD0xMjc3MDczNjE0JmVtYWlsaWQ9Y2VyYXNhbGUzMTRAZ21haWwuY29tJnVzZXJpZD1jZXJhc2FsZTMxNEBnbWFpbC5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&115&&&http://www.gpo.gov/fdsys/pkg/FR-2011-08-15/pdf/2011-20652.pdf
The recommendations in this guidance are intended to provide greater clarity on FDA’s decision-making process with regard to benefit-risk determinations in the premarket review of medical devices. Comments due by November 14, 2011.
Comment Request; Experimental Study: Disease Information in Branded Promotional Material
http://www.gpo.gov/fdsys/pkg/FR-2011-08-16/pdf/2011-20814.pdf
This notice solicits comments on research entitled ‘‘Experimental Study: Disease Information in Branded Promotional Material.’’ The proposed research will explore the nature of including information about a disease and promotional information about a specific drug treatment in the same advertising piece. Comments due by October 17, 2011.
ANNOUNCEMENTS:
Sept. 30 Webinar: Prescription Drug Shortages
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm272223.htm
FDA will host a webinar that addresses how the agency helps reduce the impact of drug shortages for patients and our nation’s health care system.
FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011 (Sept 21)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm272872.htm
FDA says users of epinephrine inhalers containing chlorofluorocarbons should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.
FDA hosted a stakeholder teleconference concerning the phase-out of Epinephrine CFC Metered-Dose Inhalers on September 21. A replay is available until October 22. To hear the replay, callers can dial 866-501-8768
New! Availability of Spanish language versions of Drug Safety Communications
http://www.fda.gov/Drugs/DrugSafety/ucm263010.htmCDER's Office of Communications has launched a new pilot program to provide Spanish language versions of the agency's Drug Safety Communications (DSCs). Given various time and review constraints, the Spanish version DSCs will generally follow the English version by about 1-2 weeks. Recent Spanish version DSCs:
Reclast (ácido zoledrónico) - Nueva contraindicación y advertencia actualizada sobre el deterioro renal causado por Reclast (ácido zoledrónico) http://www.fda.gov/Drugs/DrugSafety/ucm272029.htm
Saphris (maleato de asenapina) - Informe sobre reacciones alérgicas graves por el uso de Saphris (maleato de asenapina) http://www.fda.gov/Drugs/DrugSafety/ucm272031.htm
Antagonistas del factor de necrosis tumoral alfa (TNFα) - Las etiquetas de los medicamentos antagonistas del factor de necrosis tumoral alfa (TNFα) incluyen ahora advertencias sobre infección con las bacterias Legionella y Listeria [http://www.fda.gov/Drugs/DrugSafety/ucm272011.htm ]
Consumer Updates:
FDA's MedWatch Safety Alerts: August 2011
Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm247196.htm
UPCOMING MEETINGS:
Medical Device Alarms Summit
http://www.aami.org/alarms/
DATE: October 4-5, 2011
LOCATION: Hyatt Dulles Hotel, 2300 Dulles Corner Blvd., Herndon, Virginia
Stakeholders will develop priorities on the key issues with the safety and effectiveness of medical device/system alarms.
Public Meeting - Advancing Regulatory Science for Highly Multiplexed Microbiology/MCM Deviceshttp://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm267410.htm
DATE: October 13, 2011
LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD
The purpose of the public meeting is to discuss performance evaluation of highly multiplexed microbiology/medical countermeasure devices, their clinical application and public health/clinical needs, and quality criteria for establishing the accuracy of reference databases .
Immunology Devices Panel of the Medical Devices Advisory Committee Meeting
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm266995.htm
DATE: October 14, 2011
LOCATION: Hilton Washington DC North/Gaithersburg, salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.
The committee will discuss the Progensa PCA3 assay indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results.
Peripheral and Central Nervous System Drugs Advisory Committee Meeting
Public Meeting - Prescription Drug User Fee Act Reauthorization
http://www.gpo.gov/fdsys/pkg/FR-2011-09-12/pdf/2011-23251.pdfDATE: October 24, 2011
LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD
The purpose of the public meeting is to a discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act, which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years 2013 through 2017.
Allergenic Products Advisory Committee Meeting
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm273065.htm
DATE: October 25, 2011
LOCATION: Hilton Washington DC/Silver Spring, 8727 Colesville Rd., Silver Spring, MD
The committee will discuss CBER’s review of scientific and medical literature concerning the use of non-standardized allergen extracts in the diagnosis and treatment of allergic disease.
Circulatory System Devices Panel of the Medical Devices Advisory Committee
Advisory Committee Calendar > October 26-27, 2011: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingDATE: October 26-27, 2011
LOCATION: Hilton Washington DC North/Gaithersburg, salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD
On October 26, the committee will discuss the AtriCure Synergy Ablation System used for the treatment of atrial fibrillation in patients who are undergoing open concomitant cardiac surgery. On October 27, the committee will discuss the Medtronic Ablation Frontiers Cardiac Ablation System.
Food and Drug Administration Health Professional Organizations Conferencehttp://www.gpo.gov/fdsys/pkg/FR-2011-09-09/pdf/2011-23101.pdf
DATE: October 31, 2011
LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD
The aim of the conference is to further the public health mission of the FDA through training, collaboration, and structured discussion between health professional organizations and FDA staff.
DIA/FDA Orphan Drug Designation Workshop
http://www.diahome.org/DIAHome/resources/content.aspx?type=eopdf&file=%2fproductfiles%2f27696%2f11040%2Epdf
DATE: November 2 or November 3, 2011
LOCATION: Lansdowne, VA
This will be offered as two identical one-day workshops where FDA staff from the Office of Orphan Products Development will provide regulatory assistance to sponsors developing orphan drug designation
applications.
RESOURCES:
Articles
Please visit Articles of Interest (http://www.fda.gov/ForHealthProfessionals/ArticlesofInterest/default.htm) to access articles produced by FDA and written for a health professional audience. These articles include FDA News for Health Professionals articles, as well as articles that were published in health professional journals.
Videos
MedWatch Safety Information Resources for Busy Physicians
http://www.youtube.com/watch?v=aBWth2KRvL0
A video discussing Medwatch Safety Alerts
Other Resources
FDA MedWatch Twitter
http://twitter.com/#!/FDAMedWatch
Your FDA gateway for receiving clinically important safety information on human medical products is now on Twitter. Follow us on Twitter to receive the MedWatch Safety Alerts: http://twitter.com/FDAMedWatch
For Health Professionals
http://www.fda.gov/ForHealthProfessionals/default.htm
Additional information for Health Professionals may be found on FDA’s Health Professional website.
MedWatch Safety Alerts for Human Medical Products
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/default.htm
Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.
FDA Drug Info Rounds
http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm211957.htm
A series of training videos for practicing clinical and community pharmacists.
Device Use Safety Tips
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070245.htm
Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks.
FDA Patient Safety News
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
FDA Patient Safety News is a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products.
FDA Basics
http://www.fda.gov/AboutFDA/Transparency/Basics/default.htm
Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA.
Best regards,
Office of Special Health Issues
Food and Drug AdministrationDATE: October 17, 2011
LOCATION: FDA White Oak Campus, Building 31, Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, MD
The committee will discuss AZILECT (rasagiline mesylate) Tablets for the treatment of patients with idiopathic Parkinson's disease to slow clinical progression and treat the signs and symptoms of Parkinson's disease as initial monotherapy and as adjunct therapy to levodopa.
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