As you and other public health advocates work on the front lines of the COVID-19 pandemic, we want you to know that we recognize your concerns about protecting the safety of yourselves, your families, and others you care for. The FDA's work is critical to ensuring the health and safety of the American public at any time, but is magnified during public health emergencies.
As we address the challenges of the COVID-19 pandemic, protecting the public's health, using science to guide our decisions, and facilitating access to critical medical products continue to be top priorities for the FDA.
Your six-month-old puppy, Hoover, will eat anything that isn't tied down. Like many dog owners, you know chocolate can be dangerous to your pooch. But you may not know that if Hoover sticks his nose in your handbag and eats a pack of sugarless chewing gum, the consequences could be deadly.
Sugarless gum may contain xylitol, a class of sweetener known as sugar alcohol. Xylitol is present in many products and foods for human use, but can have devastating effects on your pet.
If you think your dog may have eaten a product containing xylitol, call your vet, emergency clinic, or animal poison control center right away.
Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses
Sun safety is always in season. It's important to protect your skin from sun damage throughout the year, no matter the weather. Why? Sun exposure can cause sunburn, skin aging (such as skin spots, wrinkles, or "leathery skin"), eye damage, and skin cancer, the most common of all cancers.
Skin cancer is on the rise in the U.S. The Centers for Disease Control and Prevention project there will be 106,110 new cases of skin melanomas and 7,180 deaths in 2021.
Stakeholder Call - Myocarditis and Pericarditis Update
Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discuss the suggested increased risks of myocarditis and pericarditis following COVID-19 vaccination.
FDA's Budget: Data Modernization and Enhanced Technologies
By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs
The U.S. Food and Drug Administration's mission to protect and promote the public health impacts the life of every American, every day. Our work encompasses an ever-widening array of foods, additives, cosmetics, medicines, and medical devices as the FDA regulates approximately 20 cents of every dollar spent annually by American consumers. The industries we regulate are constantly innovating, attracting skilled professionals, and upgrading their technological capabilities.
The FDA must keep pace. FDA's FY 2022 budget requests an increase of $185 million to embark on an effort to upgrade and modernize our physical and technological infrastructure, strengthen our talented workforce, and improve our scientific capability and regulatory structure.
FDA's Budget: Maternal and Infant Health and Nutrition
By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs
Nutrition during pregnancy and in early childhood is critically important in supporting the health and wellbeing of mothers and their children. The U.S. Food and Drug Administration's food and nutrition programs are well-positioned to make progress in maternal and infant health and nutrition this year, and will invest across the centers and offices involved in its foods program to make improvements in key areas related to food safety and nutrition.
This two-day public workshop will convene regulators, academic researchers, clinicians, patient advocates, and other stakeholders to share information underlying this action and gather input related to the safe use of benzodiazepines.
Featuring three medical product center tracks: Drugs, Devices, and Biologics
Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements. View Agenda.
The goal of the GREAT VI workshop is to discuss disease characteristics, natural history, and endpoints to assess treatment benefit in patients with eosinophilic gastrointestinal disorders beyond eosinophilic esophagitis and provide a forum for open discussion between stakeholders to facilitate drug development in these disorders. July 21, 2021; 10:00 AM - 3:30 PM ET
The overarching aim of this year's workshop remains the same as in past years - to provide a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials.
The goal of the GREAT VI workshop is to discuss the overall approach to drug development in celiac disease that includes an assessment of both clinical symptoms and histology. The workshop will focus the discussion on the histologic endpoints to assess treatment benefit in patients with celiac disease; regulatory framework for pediatric drug development in celiac disease; and the role of gluten challenge in clinical trials to provide a forum for open discussion between stakeholders to facilitate drug development.
As part of the FDA's ongoing effort to provide consistency and better understanding of applicable statutory and regulatory requirements for medical device remanufacturing and servicing, this webinar is intended to clarify the activities that are likely "remanufacturing" of a device and cybersecurity issues that are unique to the servicing of medical devices.
FDA will host a webinar for stakeholders interested in learning about the final guidance on Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations.
July 29, 2021; 11:00 AM - 12:30 PM ET
Registration is not required.
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.
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