If your email program has trouble displaying this email, view as a webpage.
April 1, 2022
Dear Colleague,
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.
Biden Administration Launches COVID.gov, a New One-Stop Shop Website for Vaccines, Tests, Treatments, Masks, and the Latest COVID-19Information
The Biden Administration is launching COVID.gov, a new one-stop shop website to help all people in the United States gain even better access to lifesaving tools like vaccines, tests, treatments, and masks, as well as get the latest updates on COVID-19 in their area. The Administration has worked over the past 14 months to set up over 90,000 vaccination sites, make more than 400 million high-quality masks available for free, send free tests to peoples' homes, and stand up new test-to-treat sites where people can get tested and receive life-saving antivirals all in one place.
Now, with a click of a button, people will be able to find where to access all of these tools, as well as receive the latest CDC data on the level of COVID-19 in their community.
FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency. This document supersedes the guidance of the same title issued in May 2021 (which superseded the guidance of the same title issued October 2020 and reissued February 2021).
FDA's Technology and Data Modernization in Action in 2022
By: Robert M. Califf, M.D., MACC, Commissioner of Food and Drugs (pictured below), and Vid Desai, Chief Information Officer
Technology and data have disrupted our world in ways unimaginable only 20 years ago – including how the world thinks about health. The COVID-19 pandemic accelerated these changes and underscored the importance of aligning technology and data strategies to drive positive outcomes in our critical work addressing public health challenges.
From how we integrate new technology into medical product application reviews and food safety efforts, to facilitating the use of data insights to help treat disease, technology and data are ubiquitous in the work of the U.S. Food and Drug Administration. In 2021, we began an agency-wide data modernization and enhanced technologies initiative. The effort provides a framework for us to take a collaborative, centralized approach to modernizing our technical IT infrastructure and the way we manage data across the FDA.
Outreach and Collaboration During the COVID-19 Pandemic
During National Minority Health Month, we highlight the ways in which we are working to improve minority health and health equity. One aspect of "Give Your Community a Boost" centers on our continuous fight against COVID-19 and increasing health promotion through combatting misinformation and building trust with diverse communities. We continuously work to provide factual and reliable information to help consumers make the best health decisions for themselves, their loved ones, and their communities.
Over the last year, the FDA's Office of Minority Health and Health Equity (OMHHE) launched a national outreach initiative to provide health education related to COVID-19. The office developed videos to highlight the diverse researchers who worked on the COVID-19 vaccines, the process of bringing vaccines to market, and the importance of diverse communities getting vaccinated.
Improving Nutrition to Turn the Tide on Diet-Related Chronic Disease
By: Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition (pictured below)
March is National Nutrition Month, and the U.S. Food and Drug Administration is shining a spotlight on the importance of good nutrition and the big impact it has on improving people's lives and lowering the enormous costs of diet-related chronic diseases. Each year, more than a million Americans die from diet-related diseases like cardiovascular disease, diabetes and certain forms of cancers.
In 2020 alone, an estimated 800,000 people died from cardiovascular disease, an even greater number than the horrific toll of COVID-19 during that same year. And obesity, which is both a disease and a condition that increases the risk for other diet-related chronic diseases, has increased to historic levels in children and adults during the COVID-19 pandemic.
April 4 - 5, 2022 Day 1: April 4, 2022; 1:00 PM - 5:00 PM ET Day 2: April 5, 2022; 1:00 PM - 4:00 PM ET
Duke-Margolis and the U.S. Food and Drug Administration (FDA) are collaborating to host a two-day virtual public workshop focused on identifying gaps in existing opioid prescriber education offerings and core competencies that should be included in educational content for opioid prescribers and other healthcare providers, including prescriber education under a Risk Evaluation and Mitigation Strategy (REMS).
The committee will meet in open session to discuss considerations for use of COVID-19 vaccine booster doses and the process for COVID-19 vaccine strain selection to address current and emerging variants. Along with the independent experts of the advisory committee, representatives from the U.S. Centers for Disease Control and Prevention and the National Institutes of Health will participate in the meeting.
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.
The workshop will appeal to statisticians in, or consulting for, the biopharmaceutical industry, clinicians, epidemiologists, drug safety professionals, regulatory and medical scientists, and other stakeholders interested in recent statistical issues in clinical research.
In this webinar, leading academic clinicians with specialties in several therapeutic areas will share their experience with biosimilars, their perspectives on how to improve the efficiency of biosimilar evaluations, and how to increase biosimilar adoption, including the role of clinical pharmacology. Enhanced knowledge and adoption of biosimilar products will help provide more affordable choices for patients.
The U.S. Food and Drug Administration (FDA) is holding a webinar on the Foodborne Outbreak Response Improvement Plan that the agency released in early December 2021. Deputy FDA Commissioner Frank Yiannas and FDA experts across agency's human foods program will be available to explain and answer questions about the plan with the goal of raising awareness, enhancing understanding, and building support. Stakeholders are welcome to provide their insights as well as ask questions.
Whole genome sequencing enables the FDA and other public health laboratories to identify, characterize, and track foodborne pathogens based on their genetic sequence. This seminar will focus on bacterial genome sequencing using the MinION from Oxford Nanopore Technologies, an inexpensive and portable sequencer that can be used to complement current sequencing strategies.
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!
This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration · 10903 New Hampshire Ave · Silver Spring, MD · 20993-0002 · 1-888-INFO-FDA
No comments:
Post a Comment