FDA Updates for Health Professionals

November 30, 2016 UPDATES FOR HEALTH PROFESSIONALS Office of Health and Constituent Affairs ANNOUNCEMENTS OPPORTUNITIES FOR COMMENT / GUIDANCES PRODUCT APPROVALS & CLEARANCES PRODUCT SAFETY UPCOMING MEETINGS RESOURCES ANNOUNCEMENTS FDA research to help speed development of Zika virus vaccines and therapeutics A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today in PLoS Pathogens, is the description of a neonatal mouse model that provides a platform for potentially improving and expediting studies to understand the causes and effects (pathology) of the Zika virus. More information FDA's Sunscreen Guidance outlines safety and effectiveness data recommended for additional active ingredients FDA released a final guidance document that details the Agency's current thinking on the specific information we believe we need from sunscreen manufacturers or other interested parties before we can determine that a sunscreen active ingredient is GRASE for use in OTC sunscreens. This guidance will also help clarify FDA's outstanding requests for additional safety and effectiveness data on the eight active ingredients, including the importance of human absorption data. More information LIVE HEALTHCARE PROFESSIONAL DDI WEBINAR SERIES " Understanding Abuse Deterrent Opioids" FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is presenting a series of continuing education webinars targeting the needs of healthcare professionals and future clinicians. "DDI Webinar Series: " Understanding Abuse Deterrent Opioids" Will be held on: December 8, 2016  Time: 1:00 pm to 2:00 pm (EST) To register for the online meeting, please visit:https://collaboration.fda.gov/ddi120816/event/registration.html OPPORTUNITIES FOR COMMENT / GUIDANCES FDA Reopens Comment Period on Draft Guidance Concerning the Type and Quality of Scientific Evidence Underlying Structure/Function Claims Made in Infant Formula Labels and Labeling The FDA is reopening the comment period on the draft guidance for industry about the type and quality of scientific evidence substantiating structure/function claims made in infant formula labels and labeling. The FDA is taking this action in response to requests for additional time to submit comments. The comment period reopened on November 21, 2016 for 90 days. More information Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made in light of the risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroid. More information Guidance: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization This guidance identifies the content and format for certain labeling components for permanent, hysteroscopically-placed tubal implant devices intended for female sterilization. FDA believes this guidance will help to ensure that a woman receives and understands information regarding the benefits and risks of this type of device prior to undergoing implantation. More information  PRODUCT APPROVALS & CLEARANCES For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed FDA approves Intrarosa for postmenopausal women experiencing pain during sex FDA approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). More information PRODUCT SAFETY MedWatch, The FDA Safety Information and Adverse Event Reporting Program For 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. DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk NutriVitaShop, also doing business as Naturecom Inc. Lake Forest, CA is requesting the nationwide recall of its DMAA net weight 500g because there may be presence of DMAA. Lot numbers include #20141102, 20150715, 20151022, 20160226, 20160701, 20161017 and 20150323. DMAA net weight 500g is packaged in approximately 8" x 11" silver and clear mylar ziplock bags that contain 500g of DMAA. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract.More information  Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids Raritan Pharmaceuticals, a contract manufacturer for Homeolab USA, is voluntarily recalling homeopathic products containing belladonna extract (see products below) due to the potential for variation in the content of belladonna extract in the products. The FDA has tested some products and recovered varying levels of belladonna extract content from what is declared on the label.More information  FindrWIRZ Guidewire System by SentreHeart: Class I Recall - Coating Separation SentreHeart is recalling the FindrWIRZ Guidewire System because the PTFE coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. Coating separation may be caused by issues with the device design or manufacturing processes. Lot Numbers 01160568, 02160586, 07160639 -150, distributed between June 1, 2016 - September 26, 2016 and manufactured between January 4, 2016 - July 22, 2016 are affected. More information  Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry due to FDA concerns over the lack of sterility assurance of the drugs named in this recall. More information Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. More information For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program 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. Public Workshop - The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance (Dec 5) Hospitals play a critical role in the development of these national capabilities, leading to more robust evidence generation. Recently, the role of hospital reporting of device-related adverse events in device surveillance and, more generally, device evaluation, has garnered increased scrutiny. This public workshop will further explore the critical role of hospitals in the evolution of device surveillance and in creating more robust surveillance capabilities. More information Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee  (Dec 6) The committee will discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis. More information Ninth Annual Sentinel Initiative Public Workshop (Feb 2)  FDA is announcing a public workshop to be held on February 2, 2017, entitled "Ninth Annual Sentinel Initiative Public Workshop." Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with the 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 the FDA's Sentinel Initiative, an overview of the current state of Sentinel System safety surveillance activities, and accomplishments of the Sentinel System in 2016. 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 Initiative projects. More information  RESOURCES 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 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 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. 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