FDA Updates for Health Professionals

July 17, 2013

PRODUCT SAFETY Class I Recall: Medtronic MiniMed Paradigm Insulin Infusion Sets - Potential for Over or Under Delivery of Insulin On June 7, 2013, Medtronic sent an urgent medical device safety notification to healthcare professionals to inform them of the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. More information June 2013 Safety Labeling Changes The MedWatch June 2013 Safety Labeling Changes posting includes over 44 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The "Summary Page" provides a listing of product names and safety labeling sections revised: More information  Class I Recall: Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades - Risk of Blade Tip Breakage and Premature Failure GlideScope GVL and AVL reusable blades were recalled due to the potential risk of breakage and premature failure of the blade tip. Device failure may not be readily visible during routine inspection before or after insertion of the laryngoscope. This could result in pieces of the blade breaking off in patients’ mouths and being swallowed or blocking the airway. This product may cause serious adverse health consequences, including hypoxemia (low blood oxygen), severe cuts to the airway leading to a significant loss of blood, and/or death. More information  Recall: Estarylla (norgestimate and ethinyl estradiol) - Report of Placebo Tablet Present in Row of Active Tablets Sandoz notified the public it is conducting a voluntary nationwide recall to the retailer level of one lot of its Estarylla (norgestimate and ethinyl estradiol) tablets in the US, following a customer report of a placebo tablet present in a row of active tablets on one pack. The lot number, expiration date, and NDC code of the recalled lot is: LF01213A, expiration date 02/2014, NDC 00781-4058-15.  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 new treatment for a type of late-stage lung cancer FDA approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations. Gilotrif is being approved concurrently with the therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations. More information  FDA permits marketing of first brain wave test to help assess children and teens for ADHD FDA allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old.  When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing should focus on ADHD or other medical or behavioral conditions that produce symptoms similar to ADHD. The device, the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, is based on electroencephalogram (EEG) technology, which records different kinds of electrical impulses (waves) given off by neurons (nerve cells) in the brain and the number of times (frequency) the impulses are given off each second. More information FDA permits marketing of quicker method for checking effectiveness of medical device steam sterilization FDA allowed marketing of the Verify Cronos Self Contained Biological Indicator (SCBI), a new test that can help speed the determination of whether steam sterilization of reusable medical devices is effective.The first biological indicator test that gives results in two hours, the SCBI is used in reprocessing, a multistep process to clean and disinfect or sterilize reusable medical devices. Properly reprocessed reusable medical devices can be used safely for more than one patient. 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: 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: Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information This draft guidance provides recommendations on when to use a Dear Health Care Provider (DHCP) Letter, the types of information to include in a DHCP letter, how to organize that information, and formatting techniques to make the information more accessible. The draft guidance is intended to improve the quality of DHCP letters to make them more effective communication tools for new information about marketed products. Comments are due by August 8, 2013. More information 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: Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics: Availability The purpose of this draft guidance is to provide a single resource for information on FDA's policies and procedures related to expedited drug development and review programs. The following programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of serious or life-threatening conditions (expedited programs): Fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. Comments are due by August 26, 2013. More information Request for Comments: Testing Communications on Medical Devices and Radiation-Emitting Products This notice solicits comments on communication studies involving medical devices and radiation-emitting products regulated by FDA. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health. Comments are due by September 09, 2013. More information Request for Comments: Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug Administration Safety and Innovation Act Section 1138 On July 9, 2012, President Obama signed FDASIA (Pub. L. 112-144) into law. Section 1138 of FDASIA requires that FDA review and modify, as necessary, the FDA communication plan to inform and educate health care providers and patients on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.Section 1138 of FDASIA requires that FDA shall publicly post the communication plan on the Internet Web site of the Office of Minority Health of FDA, and provide links to any other appropriate Internet Web site, and seek public comment on the communication plan. Comments are due by September 9, 2013. More information  Request for Comments: Administrative Detention of Drugs Intended for Human or Animal Use FDA is proposing a regulation to implement administrative detention authority with respect to drugs intended for human or animal use as authorized by amendments made to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Food and Drug Administration Safety and Innovation Act (FDASIA). Once the applicable regulation is finalized, FDA's administrative detention authority with respect to drugs will allow FDA to better protect the integrity of the drug supply chain. Comments are due by September 13, 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  ANNOUNCEMENTS Consumer Update:Safety Problems With Your Child's Medical Device? As technology provides more health care options, children are frequently diagnosed or treated with one or more medical devices. If there are problems that prevent the safe use of pediatric medical devices, FDA wants to know about them. FDA wants caregivers to report problems or concerns to help ensure that pediatric devices can be used safely and deliver the intended benefits. And the agency wants to hear about the problems when they happen, especially if they might jeopardize the safety or care of a child. More information Why FDA Proposes an ‘Action Level’ for Arsenic in Apple Juice FDA is acting to help ensure that consumers do not come in contact with apple juice that has levels of inorganic arsenic that exceed 10 parts per billion. That’s the same level that the Environmental Protection Agency (EPA) has set for drinking water, which is consumed in much greater quantities. More information  BeSafeRx: Know Your Online Pharmacy FDA BeSafeRx is a national campaign to raise awareness of the dangers of buying prescription medicines from fake online pharmacies. This campaign provides the resources to help consumers. More Information  UPCOMING MEETINGS FDA advisory committee 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. 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  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  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 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 Nonprescription Drugs Advisory Committee (Jul 31) The committee will discuss data submitted by sanofi-aventis U.S., LLC to support a supplemental new drug application (sNDA) 20468/S-035, for the switch from prescription to over-the-counter (OTC) of triamcinolone acetonide nasal spray. The proposed OTC use is “temporarily relieves these symptoms of hay fever or other upper respiratory allergies: Nasal congestion, runny nose, sneezing, itchy nose.” The applicant proposes to label the product for OTC use in adults and children. 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  Cardiovascular and Renal Drugs Advisory Committee (Aug 6) The committee will discuss new drug application (NDA) 204819, proposed trade name ADEMPAS (riociguat coated tablet), submitted by Bayer HealthCare Pharmaceuticals Inc., for the treatment of: (1) Chronic thromboembolic pulmonary hypertension World Health Organization (WHO) Group 4 to improve exercise capacity and WHO functional class and (2) pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class, and to delay clinical worsening. More information Risk Communications Advisory Committee (Aug 16) On August 16, 2013, the Committee will discuss how FDA can communicate more effectively with health care professionals and other stakeholders about the public health risks posed by counterfeit and unapproved drugs, in addition to safe purchasing practices, and how FDA can evaluate that communication and its impact. More information Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee (Sept 9) The joint committee, convened by the Office of the Commissioner, will discuss current evidence on the risks and benefits of computed tomography colonography for screening of asymptomatic patients for colorectal cancer. The joint committee will provide advice that will assist FDA's consideration of evolving research on this topic and inform the Agency's continuing regulation of these devices. More information Great Lakes cGMP & Regulatory Science Forum (Sept 24-25) This 2-day forum in Chicago, IL will feature experts from FDA, industry, and academia who will discuss the current initiatives to enhance regulatory science, pharmaceutical manufacturing and product quality. More information Public Meeting on Narcolepsy Patient-Focused Drug Development (Sept 24) FDA is conducting a public meeting on Patient-Focused Drug Development for narcolepsy. FDA is interested in obtaining patient input on the impact of narcolepsy on daily life and the available therapies for narcolepsy. 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