miércoles, 28 de diciembre de 2016

FDA Updates for Health Professionals

UPDATES FOR HEALTH PROFESSIONALS

Office of Health and Constituent Affairs

ANNOUNCEMENTS

Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety and Advancing Technology

Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends throughout the product’s lifespan. We’re pleased to announce that industry now has advice from FDA across this product continuum with the release of a final guidance on the postmarket management of medical device cybersecurity. More information

Addressing the Opioid Epidemic

In this FDA audio podcast, Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock discusses the FDA’s actions to implement the Opioid Action Plan, including important safety labeling changes. More information

Academic Medical Centers and FDA – Working Together for the Future

FDA and the nation’s academic medical centers (AMCs) have a rich history together. Many of us at FDA trained and worked at AMCs, and many of us will go back to AMCs when we leave FDA. AMCs are where much of the basic science of medicine is advanced, and where the fundamental concepts for many of the tools to test for and treat illnesses are initially developed. Increasing numbers of AMCs have regulatory science programs, FDA has memoranda of understanding with numerous AMCs, and we are pleased to host a number of fellows from AMCs annually. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Postmarket Management of Cybersecurity in Medical Devices

FDA recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to health and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the overall risk to health. More information

Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

FDA has developed this guidance document to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. This guidance is not intended to limit FDA action; rather, it describes the general framework for medical device decision making in the product availability, compliance, and enforcement arenas. More information

Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”)

FDA is issuing this guidance to describe the Center for Devices and Radiological Health’s (CDRH) policy for notifying the public about medical device “emerging signals.” This guidance describes the factors CDRH intends to consider in deciding whether to notify the public about an emerging signal, and the processes and timelines it should follow in issuing and updating the notification. Timely notification about those emerging signals based on the factors described in this guidance document is intended to provide health care providers, patients, and consumers with access to the most current information concerning the performance and potential benefits and risks of marketed medical devices so that they can make informed patient management decisions about their treatment and diagnostic options. More information

PRODUCT APPROVALS & CLEARANCES

FDA approves first drug for spinal muscular atrophy

FDA approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is an injection administered into the fluid surrounding the spinal cord. More information

FDA grants accelerated approval to new treatment for advanced ovarian cancer

FDA granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test. More information

FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions

FDA expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes. This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test. The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions. More information

FDA permits marketing of new tissue expander for women undergoing breast reconstruction following mastectomy

FDA allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities. A patient uses a dose controller to independently inflate the expander. More information

FDA approves Eucrisa for eczema

FDA approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as "eczema," which is a general term for the several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema and onset typically begins in childhood and can last through adulthood. 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

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.

Potential Problems with Battery-Powered Mobile Medical Carts in Health Care Facilities that May Result in Fire: Letter to Health Care Professionals

The FDA is warning health care facilities of potential safety risks associated with battery-powered mobile medical carts. The FDA is aware of reports of explosion, fires, smoking, or overheating of equipment that required hospital evacuations associated with the batteries in these carts. More information

ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions

IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing. More information

Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization

Greatbatch Medical is recalling the Standard Offset Cup Impactor with a POM-C handle that failed sterility testing when sterilized in a dedicated instrument case. Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death. More information

Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised

Based on an FDA review of a large clinical trial that FDA required the drug companies to conduct, FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. 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.

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

Public Workshop - Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI), February 2, 2017

The purpose of the public workshop is to obtain stakeholders' input on the coordination of registries for Devices Used for Acute Ischemic Stroke Intervention. FDA is soliciting input on all aspects of the workshop topics which include: Clinical Common Data Elements, Standardized Definitions, Case Report Forms, Informatics, Sustainability, Data Quality, and additional scientific, methodological, and clinical considerations for evaluating information obtained from registries. More information

FDA and USP Workshop on Standards for Pharmaceutical Products-“Critical Importance of Excipients in Product Development – Why Excipients are Important Now and In the Future” (Feb 27-28)

A discussion of how the quality and variability of excipients currently impact medicines and how they are expected to impact new technologies such as Continuous Manufacturing and Novel Delivery systems. More information

RESOURCES

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

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