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.
5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17
From babies to teenagers, people need vaccines throughout childhood to provide them with immunity from potentially dangerous infectious diseases. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in the United States may resurface. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for emergency use to prevent COVID-19 in people 12 and older. The Centers for Disease Control and Prevention (CDC) recommends COVID-19 vaccination for everyone 12 and older.
Emergency use authorization (EUA) allows these vaccines to be distributed in the U.S. Learn more about EUAs for COVID-19 vaccines from the FDA's Center for Biologics Evaluation and Research (CBER).
Stakeholder Call: Preparing for the School Year - Younger Children & Adolescent Vaccine Updates
On Friday, August 13, 2021 the FDA held a stakeholder call in recognition of National Immunization Awareness Month, to discuss younger children/adolescents and vaccines. Assistant Secretary for Health for the U.S. Department of Health and Human Services, Rachel Levine, M.D., and Director of FDA's Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. were featured speakers.
Attendees for this webinar will hear the latest updates from FDA's Center for Drug Evaluation Research (CDER) regarding policy and approaches toward manufacturing, supply chain, and inspections during the COVID19 Public Health Emergency (PHE).
The purpose and benefits of grouped submissions in eCTD format to the Office of Prescription Drug Promotion (OPDP), the content and structure of grouped submissions to OPDP in eCTD format, common errors associated with grouped submissions and how to avoid them.
The purpose of this workshop is to discuss opportunities for leveraging complex and innovative trial designs, understand the challenges with their applications, and develop solutions on how challenges in the designs can be overcome. The workshop will specifically focus on two topics of interest: bridging biomarkers in pediatric extrapolation and Bayesian techniques in pediatric studies. In addition, the workshop will allow for an open dialogue around the use of these approaches among regulators, industry, academia, and patient organizations.
Proteins used as therapeutics have become an essential part of modern medicine. Immunogenicity (anti-drug antibodies that target the protein-therapeutic) is a significant impediment to development and licensure of any therapeutic-protein. The lecture will illustrate how judicious application of tools available for immunogenicity risk-assessment can permit better decision-making during drug-development, licensure, and clinical-trials.
During this meeting, the Patient Engagement Advisory Committee (the Committee) will discuss factors the FDA and industry should consider to effectively communicate medical device recall information to patients and the public, including but not limited to content, format, methods used to disseminate the message, and timing of communication. The Committee will consider concerns patients have about changes to their device in response to a recall and ways patient perspectives could be incorporated in the FDA's and industry's benefit-risk decision-making of recalled medical devices.
October 6, 2021; 10:00 AM - 5:00 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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