Updates Consumer Updates Is Rinsing Your Sinuses With Neti Pots Safe? 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. Nasal irrigation devices — which include neti pots, bulb syringes, squeeze bottles, and battery-operated pulsed water devices — are usually safe and effective products when used and cleaned properly, says Eric A. Mann, M.D., Ph.D., a doctor at the FDA. ICYMI! Biosimilar and Interchangeable Biologics: More Treatment Choices The U.S. Food and Drug Administration has approved biosimilar medications to treat conditions such as cancer, diabetes, Crohn's disease, colitis, rheumatoid arthritis, psoriasis, and more. But what are biosimilar and interchangeable biosimilar biological medications? To answer that question, it helps to first know what biological products (biologics) are. Webinars and Virtual Workshops FDA and Center for Research on Complex Generics Co-Hosted Workshop: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions 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. August 18 - 20, 2021; 8:30 AM - 5:00 PM ET Day 1: Aug 18, 8:30 AM - 5:00 PM ET Day 2: Aug 19, 8:30 AM - 4:15 PM ET Day 3: Aug 20, 9:00 AM - 5:00 PM ET FDA Oncology Center of Excellence Presents: Conversations on Cancer: Finding Calm in the Storm: Moving Toward Physical and Emotional Wellbeing 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. August 19, 2021; 1:00 PM - 2:30 PM ET Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency 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). August 25, 2021; 9:00 AM - 1:00 PM ET Promotional Submissions in eCTD Format – Grouped Submissions 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. August 31, 2021; 1:00 PM - 2:00 PM ET 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. Did someone forward you this email? Sign up below! |
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