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.
Vaccines Protect Children From Harmful Infectious Diseases
Vaccines are essential to getting children off to a healthy start in life.
Because immunization programs of the 20th and 21st century have been so successful, many parents today have never seen the many vaccine-preventable diseases that were once common. They don't realize that those infectious diseases could reemerge. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in the United States may resurface.
Infectious diseases that used to be common in children in the United States – including polio, diphtheria, pertussis (whooping cough), rubella (German measles), and chickenpox – are preventable with vaccines approved by the U.S. Food and Drug Administration (FDA). Vaccines can prevent contagious diseases that once killed or harmed many infants, children, and adults. The FDA ensures that the vaccines children receive are safe and effective.
When you go outdoors with your infant, whether for a quick stroll in the park or a day at the beach, it's important to keep your little one out of the sun. But should you put sunscreen on your baby to protect them from the sun's bright rays? Not usually.
Your infant's sensitive skin is vulnerable to serious burns. But sunscreen isn't the answer, according to the U.S. Food and Drug Administration. That's because infants are at greater risk than adults of sunscreen side effects, such as a rash.
Traumatic Brain Injury: What to Know About Symptoms, Diagnosis, and Treatment
A car accident. A football tackle. An unfortunate fall. These things—and more—can cause head injuries. Head injuries can happen to anyone, at any age, and they can damage the brain.
Here's how damage can happen: A sudden movement of the head and brain can cause the brain to bounce or twist in the skull, injuring brain cells, breaking blood vessels, and creating chemical changes. This damage is called a traumatic brain injury (TBI).
The U.S. Food and Drug Administration continues to study TBI and encourages the development of medical devices to help diagnose and treat it.
Acting FDA Commissioner Dr. Janet Woodcock and FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks participated in a media call to discuss FDA's approval of the first COVID-19 vaccine.
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.
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.
The virtual conference will bring together outsourcing facilities, regulators and industry leadership to engage on emerging industry topics and best practices to improve the overall quality of compounded drugs, focusing on a culture of quality.
An optional pre-conference session geared toward first time attendees will be held on September 13, 2021.
September 14 - 15, 2021
Day 1: - ET Day 2: - ET
Registration is tentative until approved. Conference registration is free and includes access to an interactive platform as well as live sessions and presentations. Early registration is recommended.
The FDA Oncology Center of Excellence presents Conversations on Cancer - The Future of Childhood Cancer Drug Development: Is the Sky the Limit? Join this 1 ½ hour informal panel discussion exploring personal perspectives from survivors, clinicians, caregivers, and pediatric patient advocates on the impact of childhood cancer.
The FDA is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027.
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 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.
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