FDA Updates for Health Professionals

December 30, 2016 ANNOUNCEMENTS OPPORTUNITIES FOR COMMENT / GUIDANCES PRODUCT APPROVALS & CLEARANCES PRODUCT SAFETY UPCOMING MEETINGS RESOURCES ANNOUNCEMENTS FDA updates blood donor deferral policy to reflect the most current scientific evidence and continue to ensure the safety of the U.S. blood supply FDA issued final guidance outlining updated blood donor deferral recommendations to reflect the most current scientific evidence and to help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products. The FDA is changing its recommendation that  men who have sex with men (MSM) be indefinitely deferred – a policy that has been in place for approximately 30 years – to 12 months since the last sexual contact with another man. These updated recommendations better align the deferral period for MSM with the deferral period for other men and women at increased risk for HIV infection – such as those who had a recent blood transfusion or those who have been accidentally exposed to the blood of another individual. The FDA examined a variety of recent studies, epidemiologic data, and shared experiences from other countries that have made recent MSM deferral policy changes. More information FDA 2015: A Look Back (and Ahead) – Part 1: Medical Product Innovation Acting Commissioner, Stephen M. Ostroff, M.D. reflects on some of FDA's  key accomplishments in 2015 in a 3-part blog series. Part 1 focuses on medical product innovation – FDA's role in making safe, effective and innovative products available to patients who need them.  More information FDA Invites Patient Organizations to Take a Place at the Podium Theresa M. Mullin, Ph.D., is Director of FDA's Office of Strategic Programs in the Center for Drug Evaluation and Research discusses FDA's Patient-Focused Drug Development (PFDD) program. PFDD allows the FDA to obtain the patient perspective on certain diseases and their treatments. The effort is part of an FDA commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA). More information It's Still Not Too Late to Get Your Flu Vaccine Meant to get vaccinated in the fall to ward off the flu, but somehow didn't get around to it? Think it's too late to get vaccinated now? Not so. According to the FDA, vaccinations can be protective as long as flu viruses are circulating. FDA plays a key role in ensuring that safe and effective influenza vaccines are available every flu season. More information FDA Enforcement - Protecting Consumers and Enhancing Public Confidence Michael R. Taylor, J.D., is FDA's Deputy Commissioner for Foods and Veterinary Medicine, and Howard Sklamberg, J.D., is FDA's Deputy Commissioner for Global Regulatory Operations and Policy highlight the  case of Raw Deal, Inc., a manufacturer of dietary supplements based in Flanders, N.J. iin a recent FDA Voice Blog. The case illustrates the careful field work, close teamwork, and skillful investigation that are hallmarks of FDA criminal enforcement, which plays a vital role in food and dietary supplement safety.  More information  FDA encourages stakeholders to initiate eSource development projects The FDA  is encouraging stakeholders to initiate eSource development projects, using established data and implementation standards for data in a regulated clinical research environment. This news is related to the recent Federal Register (FR) Notice released by the FDA in June 2015 encouraging organizations to propose demonstration projects and the September 2013 FDA Guidance encouraging use of electronic source data in the conduct of clinical investigations. More information OPPORTUNITIES FOR COMMENT / GUIDANCES Proposed order: Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response FDA is issuing a proposed order to reclassify the electroconvulsive therapy device (ECT) for use in treating severe Major Depressive Episode (MDE) associated with Major Depressive Disorder (MDD) or Bipolar Disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.  The proposed order would reclassify ECT devices for these specific uses from Class III to Class II with special controls for these indications.  The FDA is also proposing to require manufacturers of these devices to file premarket approval applications (PMAs) for ECT devices for other intended uses, such as schizophrenia and catatonia. The FDA is also issuing a draft guidance document with recommendations for contents of 510(k) submissions and complying with the proposed special controls.  More information FDA Requests Comments on Use of the Term "Natural" on Food Labeling In direct response to requests from the public, the FDA has extended the comment period for the Use of the Term "Natural" on Food Labeling. The comment period will now end on May 10, 2016. Due to the complexity of this issue, the FDA is committed to providing the public with more time to submit comments. The FDA will thoroughly review all public comments and information submitted before determining its next steps. More information  FDA proposes tanning bed age restrictions and other important safety measures FDA is proposing steps ‎to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of using these devices for adults. The FDA is committed to protecting public health by informing consumers of the risks of indoor tanning. The FDA is issuing two proposed rules. The first proposed rule would restrict use of sunlamp products to individuals 18 and older. In addition adult users over age 18 would have to sign a risk acknowledgement certification every six months that states that they have been informed of the risks to health that may result from use of sunlamp products. The FDA also issued a second proposed rule  that would require that sunlamp manufacturers and tanning facilities take additional measures to improve the overall safety of these devices.  More information PRODUCT APPROVALS & CLEARANCES FDA approves Zurampic to treat high blood uric acid levels associated with gout FDA pproved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Zurampic works by helping the kidney excrete uric acid by inhibiting the function of transporter proteins involved in uric acid reabsorption in the kidney. More information FDA approves new orphan drug to treat pulmonary arterial hypertension FDA approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation. More information FDA permits marketing of fecal continence restoration system FDA approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options. More information FDA approves wearable defibrillator for children at risk for sudden cardiac arrest FDA approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent. More information FDA approves Basaglar, the first "follow-on" insulin glargine product to treat diabetes FDA approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. More information For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed PRODUCT SAFETY Need Safety Information? For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by email subscribe here. Class I Recall: Etest PIP/TAZO/CON-4 PTC 256 by bioMérieux:  – Potential for Test Result Error Test results may indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria when it may not actually be effective in treating. This error may result in inappropriate treatment of a patient's infection and could cause serious patient health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death.  More information Recall: La' Trim Plus, Jenesis and Oasis by BeeXtreme - Undeclared Drug Ingredients Recent Analysis by the FDA has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement "La' Trim Plus", "Oasis", and "Jenesis".  The recall includes all lots and expiration dates.  Sibutramine is an appetite suppressant and is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious, gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. More information Class I Recall: Perseus A500 Anesthesia Workstation by Draeger  - Faulty Power Switch May Cause Device to Stop Working Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly. If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen.  This could cause patients to suffer serious adverse health consequences, including injury or death. More information Safety Communication: ED-530XT Duodenoscopes by FUJIFILM Medical Systems, U.S.A. - FUJIFILM Medical Systems Validates Revised Reprocessing Instructions FUJIFILM Medical Systems, U.S.A., Inc. issued revised, validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. As noted in FDA's February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing. FDA recommends implementing the revised reprocessing instructions as soon as possible. More information Recall: Apexxx by Nuway Distributors - Undeclared Drug Ingredient FDA analysis found Apexxx to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED). Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels that may be life threatening. Additionally, the product may cause side effects, such as headaches and flushing. More information Recall: Various Products Distributed for Weight Loss by Bee Extremely Amazed - Undeclared Drug Ingredients Bee Extremely Amazed LLC, Jewett, OH is voluntarily recalling various products marketed for weight loss due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein.  Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in 2010, is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. More information FDA Safety Communication: Hand-held Laser Pointers - Risk of Eye and Skin Injuries FDA is reminding consumers about the risk of eye and skin injuries from exposure to products containing lasers. Although most toys with lasers are safe and comply with performance standards, some laser products such as hand-held laser pointers are being misused as toys. Lasers that emit more than 5mW visible light power can cause irreversible eye injury of increasing severity as the power increases. High-powered laser pointers can irritate or even burn the skin. 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. Psychopharmacologic Drugs Advisory Committee Meeting (Jan 12) The committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc., on behalf of Titan Pharmaceuticals for the proposed indication of maintenance treatment of opioid dependence. More information Vaccines and Related Biological Products Advisory Committee Meeting (Jan 14) The committee will hear updates of the research program in the Laboratory of Method Development, Division of Viral Products, Center for Biologics Evaluation and Research, FDA. The committee will meet by teleconference. More information Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity (Jan 21-22) FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex challenges in medical device cybersecurity that impact the medical device ecosystem. The purpose of this workshop is to highlight past collaborative efforts, increase awareness of existing maturity models which are used to evaluate cybersecurity status, standards, and tools in development, and to engage the multi-stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device cybersecurity. More information Public Workshop – Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy (Jan 25) The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA's process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. More information The Twentieth FDA CASSS Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products  (Jan 26) Objectives of this meeting include discussing the latest bio-analytical methods and their practical application to biotechnological pharmaceuticals (BPs) and other health-related products, and soliciting feedback from industry, academia, government, and other stakeholders on advancements in bio-analytical methods and their application to BPs. More information Eighth Annual Sentinel Initiative Public Workshop (Feb 3) Convened by the Center for Health Policy at the Brookings Institution and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA's Sentinel Initiative, including an overview of the transition from the Mini-Sentinel pilot to the full Sentinel System and key activities and uses of the Sentinel System accomplished in 2015. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel projects. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, will provide the morning keynote address. More information Psychopharmacologic Drugs Advisory Committee Meeting (Feb 3) The committee will discuss cognitive dysfunction in major depressive disorder (MDD). This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity. The committee will consider the clinical presentation of cognitive dysfunction in MDD, as well as methods for assessing this condition. The committee will also discuss new drug application 204447/supplemental new drug application 006, for the effectiveness of vortioxetine for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc. More information Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 18) The Committee will discuss and make recommendations on clinical trial, postapproval study design, and physician training requirements for leadless cardiac pacemaker device technology.  Specifically, the Committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for postapproval study collection. More information Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 19) The Committee will discuss the premarket application for the DIAM Spinal Stabilization System.  The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to moderate lumbar degenerative disc disease (DDD) at a single level from L2-L5.  More information RESOURCES For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch 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 MedWatchLearn - Practice Reporting to FDA! This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA. More information    FDA Expert Commentary and Interview Series on Medscape As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices More information   Cardiovascular and Endocrine Liaison Program The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA. More information 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 Subscriber Services: Manage Preferences  |  Unsubscribe  |  Help with this service Stay Connected:   This email was sent to bsamad2007.adnan@blogger.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)