Updates Consumer Updates For Women: The FDA Gives Tips to Prevent Heart Disease More women die from heart disease than from any other cause: about one in five American women, according to the Centers for Disease Control and Prevention. But you can take action now to reduce your risk. Resources from the FDA can help women of all ages learn how to use FDA-approved drugs and devices safely to prevent and treat heart disease. The FDA offers fact sheets, videos, and other web-based tools to teach you not only about heart disease, but also conditions like diabetes and high blood pressure, which can increase a woman's heart disease risk. The FDA also offers the "Heart Health for Women" site to connect women to agency resources to support heart-healthy living. Visit the website at www.fda.gov/womenshearthealth. In honor of American Heart Month in 2020, the FDA Office of Women's Health launched a new educational video to help spread the word about cardiovascular disease and women's heart health. This educational video is part of a new initiative to share knowledge and news on women's health (KNOWH). [2/03//2021] FDA Voices FDA Steps Up Efforts to Protect Consumers from Food Allergens By: Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition Millions of Americans have food allergies and may experience adverse reactions to products that contain food allergens. Eight foods have been identified as major food allergens, and the FDA is aware of other food allergens, such as sesame. Most allergic reactions cause mild symptoms, but some are severe and may even be life-threatening. The FDA uses its authorities to help protect those with food allergies and is implementing initiatives to build on the agency's important work. Our goals are to provide consumers with the information they need to make informed decisions, to enforce regulations that require the industry to properly label food allergens, and to significantly minimize or prevent the presence of undeclared major food allergens in food. [1/28/2021] FDA Insight | | Join FDA leaders as they provide their insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics. | Webinars and Virtual Workshops Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement The committee will discuss supplemental biologics license application (sBLA) 125514/s-089, for KEYTRUDA (pembrolizumab), submitted by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. February 9, 2021; 10:00 AM - 2:00 PM ET Registration is not required. SHIP-MD Virtual Public Workshop – Pediatric Medical Devices Through a cooperative agreement with the Critical Path Institute (C-Path), the FDA Center for Devices and Radiological Health (CDRH) is announcing a 3-day virtual public workshop, System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) 2021 Virtual Workshop. The purpose of this workshop is to bring together stakeholders interested in pediatric medical device development to review, discuss, and gather feedback on the strategic framework for SHIP-MD. Free registration will be available up to the workshop. February 9 - 11, 2021; 10:00 AM ET – 1:00 PM ET Register for this event here. Workshop on Evaluating RWE from Observational Studies in Regulatory Decision-Making FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on considerations about observational (non-interventional) study design and conduct when using evidence from observational studies to inform regulatory decisions. February 16 - 17, 2021; Day 1: 1:00 PM - 5:00 PM ET, Day 2: 1:00 PM - 3:30 PM ET Register for this event here. Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement The committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Lutonix 014 Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) catheter. February 17, 2021; 9:00 AM - 6:00 PM ET Registration is not required. Conversations on Cancer Black History Month Panel Discussion, "Living with Cancer While Black Clinical Trial Barriers, Part Two" Does a Black cancer patient have equal access to clinical trial participation? How is a patient's cancer treatment and chance of survival different if they are a Black American? What actions can we each take to contribute to greater equity in the treatment of all Americans with cancer? Be sure to join this lively Oncology Center of Excellence panel discussion.
February 18, 2021; 1:00 PM - 2:30 PM ET Register for this event here. FDA Safety Report Type Flag Requirement for FAERS Submissions FDA will introduce the FAERS FDA Safety Report Type Flag and communicate how to prepare for this new requirement. February 19, 2021; 1:00 PM - 2:00 PM ET Register for this event here. Save The Date - Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic The FDA hosts webinasr regularly to share information and answer your questions about respirators and other personal protective equipment (PPE). Save the date for the next webinar: February 23, 2021; 12:00 PM - 1:00 PM ET More info to follow. About Us The FDA Stakeholder Engagement Staff reside within the Office of the Commissioner and support the FDA mission by engaging with Patient and Health Professional Organizations, Consumer Groups, Trade Associations, Think Tanks and other external stakeholders. We encourage and support active engagement from external stakeholders related to policy that impacts human and animal medical products, cosmetics, tobacco, nutrition and food safety that promote health and healthy living. |
No comments:
Post a Comment