Updates For Patients and Health Care Providers At-Home OTC COVID-19 Diagnostic Tests  This page provides information about at-home over-the-counter (OTC) COVID-19 diagnostic tests. These at-home COVID-19 diagnostic tests are FDA authorized for self-testing at home (or in other locations). This means you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. Authorized at-home OTC tests are available without a prescription and are typically available online or at local retailers. Testing and other protective steps like mask-wearing and COVID-19 vaccination are essential to stop the spread of COVID-19 infection. ICYMI! 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 Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance March 1, 2022; 1:00 PM - 2:30 PM ET The U.S. Food and Drug Administration (FDA) will host a webinar for industry and other interested stakeholders to discuss and answer questions about the final guidance: Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. This guidance outlines recommended best practices to help ensure relevant, reliable, and sufficiently robust patient-reported outcome instruments are developed, modified, or adapted using the least burdensome approach. Registration is not required. Public Meeting: FDA Rare Disease Day 2022 March 4, 2022; 9:00 AM - 4:30 PM ET  The theme for FDA's Rare Disease Day is "Sharing Experiences in Rare Diseases Together." Patients, patient advocates, researchers and medical product developers may benefit from attending this public meeting on rare disease product development. During presentations and panel discussions various stakeholders will share their perspectives on and experiences in rare disease product development. FDA, MHRA, and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (2022) March 7 - 9, 2022; 7:30 AM - 12:00 PM ET FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada will provide attendees with insight into key topics, compliance trends and the opportunity to hear first-hand from regulators about lessons learned from the changing clinical trial landscape. Race & Genetic Ancestry in Medicine. A Time for Reckoning Racism March 8, 2022; 3:00 PM - 4:00 PM ET About the Presentation
In the context of the national debate over the use of race/ethnicity in clinical medicine and biomedical research, some have recommended a race/ethnicity-blind approach to medicine. This recommendation is based on the premise that race and ethnicity, as social constructs, have no utility in medicine for clinical decisions and its use perpetuates racism and health inequities. Registration is not required. RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases March 9, 2022; 11:00 AM - 12:00 PM ET  This webinar will bring together patients, caregivers, advocates, and other important stakeholders to celebrate and recognize the contributions that patients with rare diseases have made to advancements in regenerative medicine. Conversations on Cancer: "More Isn't Always Better: Understanding Cancer Treatment Tolerability" March 10, 2022; 2:00 PM - 3:30 PM ET This panel discussion will feature a diverse group of speakers, including patients, clinicians, researchers, and FDA representatives to share their unique perspectives. The speakers will discuss the importance and integration of the patient experience in evaluating tolerability (for example, through use of patient-reported outcome measures), clinician consideration of patient-reported tolerability, the impact of tolerability on treatment decisions, and dose optimization. Public Meeting: Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act March 22, 2022; 9:30 AM - 12:30 PM ET As part of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022, FDA committed to contracting with an independent third party to conduct interim and final assessments of the Program for Enhanced Review Transparency and Communication ("the Program") for 351(k) Biologics License Applications (BLAs). The purpose of the assessments is to determine the extent to which the Program improves the efficiency and effectiveness of 351(k) BLA reviews. 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! | 
No comments:
Post a Comment