News

FDA Issues Health Care Stakeholders Update

Apr 12, 2024

The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders.  You can read the FDA regulatory update for stakeholders below.

FDA Stakeholder Update Banner
April 12, 2024
Dear Colleague,
While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.

 

Updates

Consumer Updates

Ivermectin and COVID-19
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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
childhood vaccines graphic
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

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Strategies to Increase Clinical Trial Participation for Diverse Communities, A Panel Discussion with the OMHHE REACH Consortium

As 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 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. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.