FDA Updates for Health Profession​als

June 19, 2013

PRODUCT SAFETY Cybersecurity for Medical Devices and Hospital Networks FDA is recommending that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical devices and hospital networks. More information Endologix, Inc. AFX Introducer System: Class 1 Recall - Reports Of Dilator Breaking During Procedures Endologix, Inc. initiated a recall of AFX Introducer System Model S17-45 due to reports of the dilator breaking during procedures. More information Zyprexa Relprevv (Olanzapine Pamoate): FDA Investigating Two Deaths Following Injection FDA is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). More information Vecuronium Bromide For Injection by Sagent Pharmaceuticals, Inc.: Recall - Elevated Impurity Result Detected Sagent Pharmaceuticals Expands a Nationwide Voluntary Recall to All Lots of Vecuronium Bromide for Injection, 10mg Single Use Vials Manufactured by Mustafa Nevzat (MN Pharmaceuticals). More information Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint. More information Symbios GOPump and GOBlock Kits: Class 1 Recall - Potential for Excessive High Flow Rates FDA and Symbios are informing the public of a recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. The affected products may have excessively high flow rates. More information Bethel Nutritional Consulting, Inc. Bethel 30: Recall: Undeclared Drug Ingredient A sample of Bethel 30 green capsule was collected and tested by FDA and found positive for Sibutramine and Phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. More information May 2013 Drug Safety Labeling Changes Safety Labeling Changes includes 40 products with revisions to Prescribing Information. More information Comunicaciones de la FDA sobre la seguridad de los medicamentos en español Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov.Comunicaciones de la FDA For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch PRODUCT APPROVALS FDA approves Xgeva to treat giant cell tumor of the bone FDA expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor. More information FDA approves a new silicone gel-filled breast implant FDA approved the MemoryShape Breast Implant to increase breast size for use in women at least 22 years old and to rebuild breast tissue in women of any age. More information For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed OPPORTUNITIES FOR COMMENT / GUIDANCES Request for Comments: Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices FDA is seeking public comment on how to implement the drug supply chain provisions found in Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Under Title VII FDA is authorized to require that importers submit information demonstrating that their drug complies with applicable requirements of the Federal Food, Drug and Cosmetic Act before their products can enter the U.S. In addition, commercial importers must register with FDA and meet good importer practices. Comments are due by August 12, 2013. More information Request for Comments: Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research FDA is establishing a public docket for interested parties to submit to FDA comments on the Institute of Medicine’s (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research. FDA is interested in receiving information on whether some form of third-party governance should be considered for other types of industry-sponsored tobacco product research, including research to support premarket tobacco product applications and other submissions to FDA, as well as research designed to contribute to general knowledge regarding tobacco products. Comments are due by September 30, 2013. More information Request for Comments: New Approaches to Antibacterial Drug Development FDA is seeking input from the public on the following topics related to antibacterial drug development: Potential new study designs, proposed priorities for CDER guidances, and strategies intended to slow the rate of emerging resistance to antibacterial drugs. Submit electronic or written comments by July 30, 2013. More information Request for Comments: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products FDA is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. Submit either electronic or written comments on this proposed order by August 7, 2013. More information Request for Comments: Infant Formula - The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements FDA is proposing to amend the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula. Comments are due by July 1, 2013. More information Draft Guidance - Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability FDA is announcing the availability of a draft guidance for industry entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.”Submit either electronic or written comments on the draft guidance by June 24, 2013. More information Request for Comments: Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers This guidance is intended to provide information for industry, researchers, physicians, and patients about certain aspects of FDA's implementation of its regulations on expanded access to investigational drugs for treatment use. FDA has received a number of questions about implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions. Comments are due by July 8, 2013. More information ANNOUNCEMENTS Consumer Update: Foodborne Illness: Especially Dangerous for the Vulnerable If you’re part of what is called an “at-risk” or “vulnerable” population, a foodborne illness can be extremely dangerous. Learn which people are considered at risk and why, as well as safety precautions they can take to help prevent foodborne illness. More information Continuing Education Program for Nurses Mark your calendar for the upcoming July 18, 2013 continuing education program, “Best Practices for Safe Patient Handling and Mobility: Standards & Technology”, a joint effort of the American Nurses Association and the U.S. Food and Drug Administration. More information UPCOMING MEETINGS FDA advisory committe meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees. Click on "more information" for details about each meeting. Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings. Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for Comments (Jun 24) FDA is announcing the following public workshop: “The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and Explore—HoW to Improve the Health of Women.” CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The deadline for submitting comments related to this public workshop topic is July 31, 2013. More information Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 27) The committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. More information Meeting of the Drug Safety and Risk Management Advisory Committee (Jul 10) The Agency plans to discuss the risk management of Lotronex (alosetron hydrochloride) tablets which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome. The Agency will seek the committee’s comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system. More information Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices (Jul 12) FDA is announcing a day-long public meeting to discuss how to implement the drug supply chain provisions found in Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Under Title VII FDA is authorized to require that importers submit information demonstrating that their drug complies with applicable requirements of the Federal Food, Drug and Cosmetic Act before their products can enter the U.S. In addition, commercial importers must register with FDA and meet good importer practices. The purpose of the meeting is to provide an overview of Title VII, discuss how FDA plans to implement it and hear public comment about those provisions that specifically address imported drugs and importers. More information Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (Jul 17) The committee will discuss the safety and efficacy for the new drug application, proposed trade name MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, for the indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. More information Dental Products Panel of the Medical Devices Advisory Committee Meeting (Jul 18) The committee will discuss and make recommendations on the proposed regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the remaining preamendments Class III devices. More information Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (Jul 18) The committee will discuss new drug application, sugammadex sodium injection, for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at three minutes after administration of rocuronium. More information Arthritis Advisory Committee Meeting (Jul 22) The committee will discuss the Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis and the implications of using these criteria for drug approval. More information Public Workshop: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study (Jul 23) This workshop will introduce for discussion a new nonclinical paradigm for assessing TdP risk and explore the parameters for an appropriate, strong, nonclinical proarrthymia screening method as an alternative to clinical Thorough QT studies. The workshop is intended to provide a forum for stakeholders, including experts and opinion leaders from academia, industry, and regulatory agencies in the U.S., the European Union, Canada, and Asian countries, to discuss what a new framework might look like, the benefits and limitations of the current guidelines, and the importance of a uniform assay schema. More information Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Jul 24-25) On July 24, 2013, the committee will discuss Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. On July 25, 2013, the committee will discuss Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. Public Meeting: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (Jul 25-26) FDA is announcing a 2-day public meeting to obtain input on issues and challenges associated with the standardization and assessment of risk evaluation and mitigation strategies (REMS) for drug and biological products. More information Public Workshop: Clinical Development Programs for Opioid Conversion (Jul 29) FDA is announcing a public scientific workshop to address public health concerns associated with the inclusion of equianalgesic opioid conversion tables in opioid product labels. Discussion will focus on the available data supporting the use of equianalgesic opioid conversion tables, problems associated with their use, and strategies used in clinical practice to convert patients from one opioid analgesic product to another. More information Battery-Powered Medical Devices Workshop (Jul 30-31) This meeting is a way to better understand and address the potential challenges related to the design/development, selection, purchase, use, and maintenance of battery-powered medical devices. It’s also designed to initiate greater collaboration among stakeholders to develop best practices, training, and industry standards for battery-powered medical devices. More information Scientific Workshop: Tobacco Product Analysis (Jul 30-31) The purpose of this scientific workshop is to obtain input on the chemical analysis of tobacco products. The analyses of tobacco products include developing test methods and evaluating method performance to ensure the results of the analyses are reliable and accurate. This scientific workshop will focus on understanding the testing of tobacco filler and smoke from cigarettes, roll-your-own (RYO) tobacco, and smokeless tobacco products for specific chemicals. More information Cardiovascular and Renal Drugs Advisory Committee (Aug 5) The committee will discuss new drug application 204441, tolvaptan tablets, for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease. More information RESOURCES FDA Basics 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. More information FDA Voice FDA voice is the official blog from FDA's senior leadership and staff. More information Medical Prouct Safety Network (Medsun) Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety. More information