Updates Guidance Documents - Request for Comment Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders FDA is issuing this guidance to describe principles that should be considered when using Patient-Reported Outcome (PRO) instruments in the evaluation of medical devices and provide recommendations about the importance of ensuring the measures are fit-for-purpose. This guidance is not meant to replace the Patient-Focused Drug Development (PFDD) guidance series. Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders FDA is pursuing various efforts of encouraging voluntary patient engagement in clinical studies, including guidance. FDA believes medical device clinical studies designed with patient input may help to address common challenges faced in medical device clinical studies. While FDA acknowledges that patient engagement may be beneficial across the total product lifecycle, this guidance focuses on the applications of patient engagement in the design and conduct of medical device clinical studies. Consumer Updates Tips for Women 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. You can take action now to reduce your risk. Resources from the U.S. Food and Drug Administration (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 such as diabetes and high blood pressure, which can increase a woman's heart disease risk. The FDA also offers the Heart Health for Women page to connect women to resources to support heart-healthy living. Watch this FDA Office of Women's Health educational video to learn more about cardiovascular disease and women's heart health. The video is part of an initiative to share knowledge and news on women's health (KNOWH). Know Your Treatment Options for COVID-19  Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved one drug treatment for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19. Here's a closer look at some of the available COVID-19 treatments and how to get more information about them and others. Talk to your health care provider about available treatment options if you have COVID-19. Your provider will know the best option for you, based on your symptoms, risks, and health history. FDA Voices FDA on Track to Take Actions to Address Tobacco-Related Health Disparities  By: Mitch Zeller, J.D., Director, Center for Tobacco Products (pictured below) In April 2021, the U. S. Food and Drug Administration announced its intent to take significant action toward dramatically reducing tobacco-related disease and death in the U.S. The agency remains on track to advance two proposed tobacco product standards – one prohibiting menthol as a characterizing flavor in cigarettes and another prohibiting all characterizing flavors (including menthol) in cigars – by spring.  Given that each year nearly half a million people in the U.S. die prematurely from tobacco-related diseases, reducing the appeal of cigarettes and cigars will have an extraordinary public health impact. These actions are an important opportunity to achieve significant, meaningful public health gains and advance health equity. For far too long, specific populations have been targeted and disproportionately impacted by tobacco use, especially when it comes to characterizing flavors that entice them to start and keep smoking. | ICYMI! ADVANCE Study - What Can Your Blood Do?  Three of the nation's largest blood centers – Vitalant, OneBlood, and the American Red Cross – are conducting a pilot study funded by the U.S. Food and Drug Administration (FDA) that could lead to a significant change to blood donor eligibility for men who have sex with men. The study is called the ADVANCE Study, which stands for Assessing Donor Variability And New Concepts in Eligibility. What FDA's Foods Program Achieved in 2021 to Protect Consumers and the Food Supply  By: Frank Yiannas, Deputy Commissioner for Food Policy and Response Despite the unprecedented challenges we've all faced during the COVID-19 pandemic, 2021 was another important year for the U.S. Food and Drug Administration's Foods Program. I'd like to highlight some of the strides we made last year in protecting the safety of human foods, which we will continue building on this year. They reflect on the work done by the dedicated teams in the FDA's Office of Food Policy and Response, the Center for Food Safety and Applied Nutrition, and the Office of Regulatory Affairs. Webinars and Virtual Workshops Public Meetings on the Proposed Changes to Agricultural Water Requirements in the Produce Safety Rule February 14, 2022; 11:45 AM - 7:45 PM ET The U.S. Food and Drug Administration (FDA) will be holding two virtual public meetings on the recently released proposed rule "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water." The purpose of the public meetings is to discuss the proposed rule, which was issued under the FDA Food Safety Modernization Act. These public meetings are intended to facilitate and support the public's evaluation and commenting process on the proposed rule. CDER BIMO GCP Compliance and Enforcement February 16, 2022; 1:00 PM - 3:30 PM ET This webinar will: - Provide a general overview of the Bioresearch Monitoring (BIMO) program
- Discuss Good Clinical Practice (GCP) inspectional processes, compliance evaluation and enforcement, including case examples
- Summarize findings from a recent publication on follow-up inspectional activities after FDA notifies an inspected entity of serious-noncompliance
- Include live Q&A session and a moderated panel discussion
Collaborating on Culture in the New Era of Smarter Food Safety February 16, 2022; 12:30 PM - 1:15 PM ET The U.S. Food and Drug Administration and Stop Foodborne Illness, a non-profit public health organization, are collaborating on a webinar series that explores food safety culture, one of the core elements in FDA's New Era of Smarter Food Safety initiative Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices February 22, 2022; 1:00 PM - 2:30 PM ET The U.S. Food and Drug Administration (FDA) will host a webinar for stakeholders interested in learning more about the draft guidances on COVID-19 transition plans for medical devices. This webinar will: - Help prepare manufacturers and other stakeholders for the orderly and transparent transition to normal operations
- Describe recommendations regarding submitting a marketing submission and the timeline for doing so
- Provide examples to illustrate the transition policies and exemplify the 180-day transition period timeline
- Answer your questions about the draft guidances on COVID-19 transition plans
Registration is not required. Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA February 24, 2022; 1:00 PM - 3:00 PM ET In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency's recommendations regarding BE information submitted in an Abbreviated New Drug Application (ANDA) submission, provide assistance to potential ANDA applicants, and support access for patients to lower cost, high quality medicines. This webinar will take a deeper look at the revised draft guidance, describe major changes from the previous draft guidance published in 2013, and provide clarification to comments received through the public docket. For example, we received questions on study population (with regard to sex and age), and bioequivalence assessment for. 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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