Updates Consumer Updates Advice About Eating Fish  FDA and EPA have issued advice regarding eating fish. This advice can help those who might become or are pregnant or breastfeeding as well as parents and caregivers who are feeding children make informed choices when it comes to the types of fish that are nutritious and safe to eat. This advice supports the recommendations of the Dietary Guidelines for Americans. | The advice features a chart that makes it easy to choose dozens of healthy and safe options and includes information about the nutritional value of fish. A set of frequently asked questions & answers provides more information on how to use the chart and additional tips for eating fish. Should You Give Kids Medicine for Coughs and Colds?  Although most colds in children don't cause serious complications, they can cause stress and worry in parents and caregivers. It's understandable that you might want to give your child medicine to treat a cold. But most children will get better on their own, and cough or cold medicine will not change the natural course of a cold or make it go away faster.
In addition, some cough and cold medicines can have serious side effects, such as slowed breathing, which can be life-threatening, especially in infants and young children. For those reasons, it's important to know when your child needs medication, which treatments are recommended, and when to do without medicine. Watch Out for False Promises About So-Called Alzheimer's Cures Chances are, you know someone with Alzheimer's disease or a related dementia involving memory loss. That's due in part to the fact that as our older population grows, so does the number of people facing serious cognitive and related health issues. Not surprisingly, this demographic change has been accompanied by a growth in the number of marketers who prey on this population, pitching products that make unproven claims that they can prevent, treat, delay, or even cure Alzheimer's disease. Halloween Food Safety Tips for Parents  | | Even though it's not an official holiday, Halloween is much beloved by children and adults alike. What could be more fun than trick-or-treating, apple bobbing, or costume parties? | ICYMI! How CDRH's Digital Transformation Initiative Will Strengthen the Premarket Review Program  By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality (OPEQ), CDRH At the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH), we are committed to protecting the public health by ensuring patients have more timely access to safe, effective, and high-quality medical devices. This includes our responsibility to review premarket submissions for certain new medical devices and modifications to devices currently on the market. As part of this ongoing work, the FDA continues to take steps to strengthen the premarket review program and make it more efficient, consistent, and predictable. Webinars and Virtual Workshops Public Meeting on the Recommendations for Biosimilar User Fee Act (BsUFA) Reauthorization The FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027.
November 2, 2021; 9:00 AM - 12:00 PM ET Clinical Trial Endpoint Development for Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) The FDA Oncology Center of Excellence (OCE) welcomes you to the Clinical Trial Endpoint Development for Locally Advanced Head and Neck Cancer public virtual workshop. Throughout the day you will hear interactive discussions on early endpoints in locally advanced head and neck squamous cell carcinoma, event-free survival (EFS) and locoregional control (LRC), issues regarding management and defining early endpoints, and patient's perspective on clinical trial endpoints.
November 3, 2021; 12:00 PM - 5:00 PM ET Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA) FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2023 through 2027. The meeting agenda, public docket information, additional materials, and any other updates will also be posted to this website as they become available. November 16, 2021; 9:00 AM - 2:00 PM ET Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation The FDA will host a virtual Town Hall for SARS-CoV-2 test developers. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2.
November 17, 2021, 12:15 PM - 1:15 PM ET Registration is not required. Closer to Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages This meeting is the first of several expected meetings on the Closer to Zero (C2Z) action plan to receive stakeholder input. The purpose of this meeting is to discuss the scope of our action plan as it relates to the impacts of toxic element exposure and nutrition at different crucial developmental stages on growth and development. November 18, 2021; 10:00 AM - 4:00 PM ET Best Practices for Development and Application of Disease Progression Models The purpose of this public workshop is to discuss the best practices for developing disease progression models and their application to support drug development decisions, share experiences and case studies that highlight the opportunities and limitations in the development and application of disease progression models including models for natural history of disease and clinical trial simulations, and discuss the knowledge gaps and research needed to advance the development and use of disease progression models. November 19, 2021; 9:30 AM - 2:30 PM ET About Us The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. Did someone forward you this email? Sign up below! | 
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