UpdatesConsumer UpdatesIvermectin and COVID-19
One of the U.S. Food and Drug Administration’s jobs is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use. There continues to be interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Vaccines Protect Children From Harmful Infectious Diseases
Vaccines are essential to getting children off to a healthy start in life and keeping them healthy as they grow up. Because immunization programs of the 20th and 21st centuries have been so successful, many parents today have never seen the many vaccine-preventable diseases that were once common. They may not realize that those infectious diseases could reemerge. View all Official FDA Guidance Documents and other Regulatory Guidance You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.
Webinars and Virtual Workshops
Strategies to Increase Clinical Trial Participation for Diverse Communities, A Panel Discussion with the OMHHE REACH ConsortiumAs the FDA Office of Minority Health and Health Equity (OMHHE) celebrates National Minority Health Month (NMHM), we invite you to join our ongoing efforts this month to advance health equity and reduce health disparities among racial and ethnic minority and other diverse populations. Drug Development for the Treatment of Congenital Cytomegalovirus Infection and Neonatal Enterovirus Infection May 7 - 8, 2024 Day 1: Tue, May 7; 9:00 a.m. - 5:00 p.m. ET Day 2: Wed, May 8; 9:00 a.m. - 5:00 p.m. ET The FDA is holding a public, two-day workshop entitled “Development of Drugs for the Treatment of Congenital Cytomegalovirus (CMV) Infection and Neonatal Enterovirus Infection.” Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment | Role and Opportunities May 8 - 9, 2024 Day 1: Wed, May 8; 9:00 a.m. - 2:30 p.m. ET Day 2: Thu, May 9; 9:00 a.m. - 2:30 p.m. ET This co-sponsored public workshop will be hosted by the FDA Office of Clinical Pharmacology (OCP) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI). Public Workshop: In-person and Hybrid How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases May 9, 2024; 9:00 a.m. - 4:00 p.m. ET The purpose of this one-day public workshop is to provide an interdisciplinary forum to discuss the best practices of trial design, analyses, and interpretation of trials with multiple phases of treatment (e.g., resectable lung cancer, early-stage breast cancer). Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval. May 9, 2024; 1-3 p.m. ET FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. Collaborating on Culture in the New Era of Smarter Food Safety May 9, 2024; 5:15 - 6:30 p.m. ET The U.S. Food and Drug Administration and Stop Foodborne Illness, a non-profit public health organization, are collaborating on a webinar series that explores food safety culture, one of the core elements in FDA’s New Era of Smarter Food Safety initiative. Registration is not required. View Upcoming FDA Meetings, Conferences and Workshops Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts
About UsThe 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. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov. |
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