FDA UPDATES FOR HEALTH PROFESSION​ALS

April 10, 2013

PRODUCT SAFETY Class 1 Recall: BCI Remote Alarm Cables By Smith's Medical ASD, Inc: Cables Are Not Transferring Alarms Smiths Medical has become aware that, in rare instances, the BCI Remote Alarm Cables (BCI Cables) are not transferring alarms when used with some remote nurse alarm systems. These products may cause serious adverse health consequences, including death. More information Recall: ROCK-It MAN Male Enhancement Capsules: Undeclared Drug Ingredient Consumer Concepts, Inc. notified the public of a consumer/user level recall of all ROCK-It MAN Male Enhancement Capsules sold between October, 2012 and April, 2013. Analytical tests conducted by the FDA concluded that the product contained Hydroxythiohomosildenafil. More information Recall: Animas Corporation 2020 Insulin Infusion Pump: False Alarm or Warning Sound Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. More information Recall: BIVIGAM Immune Globulin Intravenous (Human), 10 Percent Liquid, 100 mL Sterile Vial: Visible Particles Observed During a routine annual reserve inspection, visible particles were observed in lot number 120016 (Expiration Date: March 31, 2014) of BIVIGAM Immune Globulin Intravenous (Human), 10% Liquid. Biotest is voluntarily recalling this lot from the market. Inspections of other lots of product have not shown the presence of visible particles. More information Recall: Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container - Brass Particulates Hospira, Inc. notified healthcare professional of a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 1000 mL, Flexible Container, NDC 0409-7983-09. This action is due to one confirmed customer report where brass particulate was identified in the primary container in the form of several small grey/brown particles. 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 AND CLEARANCES FDA approves Invokana to treat Type 2 Diabetes FDA approved approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. More information FDA approves Diclegis for pregnant women experiencing nausea and vomiting FDA approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting. 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 Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use FDA is announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. More information Request for Comments: Draft Guidance for Industry and FDA Staff - Providing Information About Pediatric Uses of Medical Devices This proposed rule would require each applicant who submits an humanitarian device exemption, premarket approval (PMA), supplement to a PMA, or product development protocol to include, if “readily available,” a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients. FDA is proposing to codify a definition of “readily-available” and also issue a draft guidance document to explain the Agency's current thinking on the meaning of “readily-available information” and how to comply with the requirements set forth in section 515A of the FD&C Act. Comments are due by April 22, 2013. More information Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies, and a Small Entity Compliance Guide FDA is announcing the availability of two guidances for industry and investigators entitled “Safety Reporting Requirements for INDs and BA/BE Studies” and “Safety Reporting Requirements for INDs and BA/BE Studies—Small Entity Compliance Guide.” These guidances are intended to help sponsors and investigators comply with the requirements for IND safety reporting and safety reporting for BA and BE studies. Submit either electronic or written comments on Agency guidances at any time. More information Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments FDA is announcing the availability of a draft 5-year plan describing the Agency's approach to further developing and implementing a structured framework for benefit-risk assessment in the human drug and biologic review process and the opportunity for public comment on the draft plan. This plan is part of FDA's commitments that were made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Comments are due by May 7, 2013. More information Requirements; Availability Request for Comments: FDA proposes new food safety standards for foodborne illness prevention and produce safety FDA proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed rules. Comments are due by May 16, 2013. More information Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act This notice solicits comments on submission of rotational plans for health warning label statements for smokeless tobacco products. Comments are due by May 17, 2013. More information Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding Regulations FDA is inviting comments from the public on whether any potential changes to the Federal drug regulations are necessary for medical gases. Comments are due by May 21, 2013 More information Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container. FDA is concerned that statements submitted for inclusion in medical product labeling, such as“latex-free,” “does not contain natural rubber latex,” or “does not contain latex” are not accurate because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. Comments are due by June 10, 2013. More information Effective Date of Requirement for Premarket Approval for Automated External Defibrillator SystemRequest for Comment: FDA is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments devices: Automated external defibrillators systems (AEDs), which includes the AED device and its accessories (i.e., pad electrodes, batteries, and adapters). Comments are due by June 24, 2013. More information Center for Drug Evaluation and Research Medical Policy Council; Request for Comments FDA is announcing the establishment of a docket to receive suggestions, recommendations, and comments for topics from interested parties, including academic institutions, regulated industry, patient representatives, and other interested organizations, on medical policy issues that may be considered by the CDER Medical Policy Council (Council) in FDA's Center for Drug Evaluation and Research (CDER). These comments will help the Agency identify and address medical policy issues that need clarification through guidance, notice and comment procedures, or other means. Comments are due by July 16, 2013. More information Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4 FDA is announcing the availability of draft guidance for industry and FDA staff entitled “Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4.” Comments can be submitted either electronic or written comments on the draft guidance by July 2, 2013. More information ANNOUNCEMENTS Consumer Update: Nicotine Replacement Therapy Labels May Change When nicotine replacement therapy (NRT) products were first marketed almost 30 years ago to help people stop smoking, there wasn't a lot of data available on how long consumers could safely use them, and whether they could be used in combination with other NRTs or continued smoking. More information Center for Devices and Radiological Health: Experiential Learning Program FDA Center for Devices and Radiological Health (CDRH or Center) is announcing an invitation for participation in its Experiential Learning Program (ELP). The purpose of this document is to invite medical device and health care facilities to participate in this formal training program for FDA's medical device review staff, or to contact CDRH for more information regarding the program. More information Pediatric Device Consortia Grant Program FDA is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia (PDC) Grant Program. The goal of the PDC Grant Program is to facilitate the development, production, and distribution of pediatric medical devices. Application due date is June 1, 2013. More information The FDA Office of Special Health Issues Has a New Name! The former Office of Special Health Issues, the FDA’s flagship contact for patients and healthcare professionals, will now be called the Office of Health and Constituent Affairs (OHCA). The Office will continue its core function of serving the needs of patients and healthcare professionals and managing the MedWatch program, but the new name showcases the emphasis placed on building a more robust and centralized office for all stakeholder engagement. 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. Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations Public Workshop (Apr 10) The purpose of this public workshop is to discuss research and development of multiplex assays and the use of these tests in blood donor screening and blood cell antigen typing. The public workshop will include presentations and panel discussions by experts from academic institutions, blood establishments, industry, and government agencies. More information National Hospice and Palliative Care Organization Webinar: Proper Medication Disposal: Current Strategies (Apr 11) This Webinar will examine the latest FDA policies and will identify other regulatory and enforcement agencies related to drug disposal. In addition, faculty will discuss current drug disposal strategies and practices, key compliance challenges and issues facing providers as well as the new DEA proposed rule on drug disposal and how it will impact hospice. More information Device Good Manufacturing Practice Advisory Committee Meeting (Apr 11) The committee will discuss the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality. More information Cellular, Tissue and Gene Therapies Advisory Committee Meeting (Apr 17) On April 17, 2013, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Chemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. More information Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting (Apr 17) The committee will discuss the new drug application fluticasone furoate and vilanterol dry powder inhaler (proposed trade name BREO ELLIPTA), for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. More information Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee Meeting (Apr 18) The committee will discuss the efficacy and safety of AVEED (testosterone undecanoate) intramuscular injection, for the proposed indication of replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil embolism in the lungs and potential anaphylactic reactions. More information International Consortium of Cardiovascular Registries (Apr 22) The purpose of this meeting is to discuss the development of an international consortium of cardiovascular registries with a broad array of interested stakeholders. More information FDA Webinar: Home Use of Diabetes and Cardiovascular Medical Devices (Apr 23) FDA's Center for Devices and Radiological Health (CDRH) and the Commissioner's Office of External Affairs, Office of Health and Constituent Affairs (OHCA) will host a 90-minute Webinar to discuss the home use of medical devices with a focus on devices used in cardiovascular disease and diabetes. More information Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop (Apr 25-26) A public workshop to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME). FDA has determined that CFS and ME are serious conditions for which there are no approved drug treatments. More information Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (Apr 25-26) The committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays, phencyclidine (PCP) enzyme immunoassays, PCP radioimmunoassays, and isoniazid test strips. More information Risk Communications Advisory Committee Meeting (Apr 29-30) The Committee will discuss general factors in risk communication about FDA-regulated products, including how to communicate effectively about FDA's adverse event reporting systems, and messaging in the context of competing communicators. More information Accessible Medical Device Labeling in a Standard Content and Format Public Workshop (Apr 29-30) The purpose of the workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. More information Oncologic Drugs Advisory Committee Meeting (May 2) The committee will discuss NDA 204408, with the established name tivozanib capsules, indicated for the treatment of advanced renal cell carcinoma, and NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), indicated for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver. More information General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting (May 2) The committee will discuss the premarket approval application for Juvéderm Voluma XC, indicated for deep (dermal/subcutaneous and/or submuscular/supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement. More information Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (May 3) The committees will discuss the safety and efficacy of currently approved leukocyte growth factors as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. More information Vaccines and Related Biological Products Advisory Committee Meeting (May 8) The committee will meet in open session via teleconference to hear an overview of the research program in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. More information Summit on Color in Medical Imaging; Cosponsored Public Workshop (May 8-9) FDA and cosponsor International Color Consortium are announcing the following public workshop entitled “Summit on Color in Medical Imaging: An International Workshop on the Technical Framework for Consistency and Interoperability Approaches for Dealing with Color in Medical Images.” The purpose of the workshop is to bring together key stakeholders to clearly identify areas of need, investigate solutions, and propose best-practice approaches. More information Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice Conference (May 15-16) FDA is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The conference on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. More information Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (May 21-22) On May 21, the committee will discuss the classification of one of the remaining preamendments class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. On May 22, the committee the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (Docket No. FDA-2009-M-0101). More information Peripheral and Central Nervous System Drugs Advisory Committee Meeting (May 22) The committee will discuss new drug application for Suvorexant tablets. The proposed indication is for insomnia characterized by difficulties with sleep onset and/or maintenance. More information 2013 Medical Countermeasures Initiative Regulatory Science Symposium (May 30) FDA is announcing the following meeting: 2013 Medical Countermeasures initiative (MCMi) Regulatory Science Symposium. The symposium is intended to provide a forum for the exchange of ideas for medical countermeasure development, highlight work on regulatory science as it applies to the development and advancement of medical countermeasures, facilitate innovative directions, and inform stakeholders on medical countermeasure. More information Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices (Jun 11-12) FDA is announcing its fifth public workshop on Computer Methods for Medical Devices entitled “FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.” More information 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 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 Product 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