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.
Development and Submission of Near Infrared Analytical Procedures This guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files.
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.
Healthy Breakfasts for Kids: It's All About Balance
A healthy breakfast is a must for kids. Skip it and your kids will be playing nutritional catch-up for the rest of the day, says the U.S. Food and Drug Administration.
Growing bodies and developing brains need regular, healthy meals. According to the Academy of Nutrition and Dietetics, studies show that school children who eat breakfast perform better in the classroom.
As with other meals, it's a good idea for your kids (and you) to eat a healthy balance of fruits and vegetables, proteins, grains and dairy—not just for breakfast but throughout the day.
Little teapots with long spouts have become a fixture in many homes to flush out clogged nasal passages and help people breathe easier.
Along with other nasal irrigation devices, these devices — commonly called neti pots — use a saline, or saltwater, solution to treat congested sinuses, colds and allergies. They're also used to moisten nasal passages exposed to dry indoor air. But be careful. Improper use of these neti pots and other nasal irrigation devices can increase your risk of infection.
The purpose of this workshop is to discuss the scientific principles and practical considerations that inform current FDA thinking and USP recommendations for IVRT and IVPT studies, explore challenging issues that would benefit from broader discussion, identify areas that would benefit from further research, and discuss opportunities for coordination and collaboration between the FDA, USP, academic institutions, product manufacturers, diffusion cell equipment manufacturers, contract research organizations, consultants, and other stakeholders.
The FDA Oncology Center of Center of Excellence presents Conversations on Cancer - Finding Calm in the Storm: Moving Toward Physical and Emotional Wellbeing. Join this 1 ½ hour informal panel discussion exploring personal perspectives from survivors, clinicians, caregivers, and behavioral health experts on the impact of cancer.
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.
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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