June 28, 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

• June 27, 2024 - FDA Permits Marketing of First Point-of-Care Hepatitis C RNA Test
• June 26, 2024 - FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies
• June 25, 2024 - FDA Roundup
• June 25, 2024 - Updates on Highly Pathogenic Avian Influenza (HPIA)
• June 21, 2024 - FDA Roundup
• June 21, 2024 - FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review

Consumer Updates

Know Which Medication Is Right for Your Seasonal Allergies

The pollen count is sky-high. You’re sneezing, your eyes are itching, and you feel miserable. Seasonal allergies are real diseases that can interfere with your life.

Seasonal allergic rhinitis, the medical term for seasonal allergies and hay fever, can also trigger or worsen asthma and lead to other health problems, such as sinus infections (sinusitis) and ear infections. The FDA regulates several medications that offer allergy relief.

Safely Soothing Teething Pain in Infants and Children

Teething is a normal experience for infants and children, but it can be painful. Many well-meaning parents and caregivers who want to ease a child’s pain might turn to products that could be harmful.

FDA Voices

The Concerning Trend in Men’s Health

By: Robert M. Califf, MD, Commissioner of Food and Drugs

During my career as an academic researcher, physician, and public health official, I’ve tried to bring attention to a startling paradox: despite unprecedented technological advances that have saved lives globally, and despite spending more on healthcare than any other nation on earth, life expectancy in the U.S. is trending downward. This concerning development, which runs counter to multiple previous decades of improvements in life expectancy, started even before the COVID-19 pandemic. But if we take a closer look at the data, it’s clear that one group in particular is falling behind—men. Let’s catch up on this.

Guidance Documents

CVM GFI #276 Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs

The recommended approach to demonstrate substantial evidence of effectiveness of an investigational new animal drug intended for the prevention of heartworm disease in dogs is for the sponsor to conduct two laboratory dose confirmation studies and one multi-site field effectiveness study in accordance with the principles of Good Clinical Practice (GCP) as described in GFI #85 (VICH GL9), “Good Clinical Practice.’’

CVM GFI #283 Priority Zoonotic Animal Drug Designation and Review Process

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, signed into law in March 2020, added section 512A Priority zoonotic animal drugs to the FD&C Act, which provides for the designation of a new animal drug as a PZAD. 

This guidance outlines the eligibility criteria a new animal drug should meet to obtain PZAD designation and describes the process sponsors may use to request such designation.

Laboratory Developed Tests: Small Entity Compliance Guide

On May 6, 2024, FDA published a final rule in the Federal Register entitled "Medical Devices; Laboratory Developed Tests" (89 FR 37286) ("LDT Final Rule").

CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use

This guidance describes the Center for Veterinary Medicine’s recommendations for the information to be included in Chemistry, Manufacturing, and Controls submissions to New Animal Drug Applications, Conditional New Animal Drug Applications, Investigational New Animal Drug files, and Veterinary Master Files specific to recombinant protein-based intermediates,  drug substances, and drug products.

CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles

This guidance provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) information for Type A medicated articles.  Type A medicated articles contain new animal drugs and provide for administration of these drugs in animal feed.

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.

ICYMI!

MCMi Program Update

FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure.

Webinars and Virtual Workshops

Public Workshop: Best Practices for Meeting Management Under PDUFA VII

July 22, 2024; 9:00 a.m. - 2:00 p.m. ET

With the increased number and types of meetings and interactions, optimizing meeting management practices have become more important to facilitate the conduct of efficient and effective drug development programs.

Introduction to FDA’s Office of Trade and Global Partnerships

July 23, 2024; 1:00 - 2:00 p.m. ET

The goal of this webinar is to provide an introduction to FDA’s Office of Trade and Global Partnerships (OTGP). OTGP serves as the FDA lead for addressing issues related to international trade of regulated products, mutual recognition agreements, and entering into arrangements and sharing information with global counterparts.

FDA’s Fifth Online Controlled Substances Summit

July 25 - 26, 2024

Day 1: Thu, Jul 25, 2024; 11:00 a.m. - 3:00 p.m. ET
Day 2: Fri, Jul 26, 2024; 11:00 a.m. -  4:00 p.m. ET

The FDA, in partnership with the Reagan-Udall Foundation for the FDA, will host the two-day virtual public meeting, "FDA’s Fifth Online Controlled Substances Summit." The goal of this summit is to identify innovative solutions to reduce the illegal availability of controlled substances online.

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.