February 2, 2026

Dear Colleague,

The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics.  Your partnership, knowledge and engagement in the public health space are appreciated.

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

• Feb. 1, 2026 - FDA Launches PreCheck Pilot Program to Strengthen Domestic Pharmaceutical Manufacturing
• Jan. 30, 2026 - The FDA to Begin Conducting Medical Device Inspections Under an Updated Process
• Jan. 29, 2026 - Outbreak Investigation of Salmonella: Moringa Leaf Powder (January 2026)
• Jan. 29, 2026 - Investigations of Foodborne Illness Outbreaks
• Jan. 28, 2026 - CDRH 2025 Annual Report
• Jan. 28, 2026 - FDA at a Glance
• Jan. 27, 2026 - FDA Approves Daratumumab and Hyaluronidase-fihj with Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma
• Jan. 27, 2026 - FDA Releases New Interactive Tool for Total Diet Study (TDS) Results and New Data
• Jan. 26, 2026 - Event Materials Available for the Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

The FDA’s medical product safety reporting program for health professionals, patients and consumers, MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products.  The most recent alerts/recalls are here:

• Why Not Natural Organic Moringa - Green Superfood by Why Not Natural

Consumer Updates

What Does FDA Approve? Part 2

Is It Really "FDA Approved"?  Part 2.
Here are 10 more facts about how the FDA works to protect public health. 

Guidance Documents

• Clinical Decision Support Software

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.

FDA Voices

A Special Year, New Seal, and Renewed Commitment to the American People

By: Marty Makary, M.D., M.P.H., Commissioner of Food and Drugs

2026 is a special year for the FDA.  It marks our 120th year of service to this nation.  In honor of this occasion, and to help the public better understand who we are and the many functions we fulfill, we’ve recently unveiled an official agency seal, our first ever.  It signifies the many public health strides we’ve made over the decades—including this past year—while also inspiring more powerful outcomes to make Americans safer and healthier, and we hope, affirm your trust in us.

ICYMI!

FDA-Approved Devices That Help Keep the Heart Beating

Heart disease, also called cardiovascular disease, can have serious consequences.  It’s the leading cause of death for adults in the U.S.  Medical devices approved by the FDA, such as pacemakers and defibrillators, have extended and improved the lives of millions of people living with heart disease.  The FDA evaluates certain devices for safety and effectiveness before they can be marketed to the public, including those used to treat cardiovascular conditions and other related issues.  Many of these FDA-approved medical devices can be implanted in a person’s body, while others are used outside the body.  Health care providers determine which cardiovascular devices, if any, are best for each patient.

Webinars and Virtual Workshops

FDA Grand Rounds – Postmarket Regulation of Cosmetic Products: The Who, What, When, Why and How

Date: Thursday, Feb. 5, 2026; noon - 1 p.m. ET

This lecture will provide a comprehensive overview of the FDA's regulatory authorities over cosmetic products.  Participants will also learn about the various tools available for industry to register their facilities and list their cosmetic products as required by MoCRA, and how industry and consumers can report adverse events from use of cosmetic products to the FDA.

Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks

Day 1: Thursday, Feb. 5, 2026; 1:30 - 5 p.m. ET
Day 2: Friday, Feb. 6, 2026; 8:30 a.m. - 4 p.m. ET

The FDA, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI), is announcing the following public workshop titled "Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks."  The aim of the public workshop is to discuss common challenges in neonatal and rare disease product development and identify opportunities to leverage rare disease product development frameworks in the neonatal product development space.

Roundtable on Premarket Tobacco Product Application (PMTA) Submissions for Electronic Nicotine Delivery Systems (ENDS) Products

Date: Tuesday, Feb. 10, 2026; 9 a.m. - 5 p.m. ET

The purpose of the roundtable is to provide small tobacco product manufacturers (fewer than 350 employees) an opportunity to share their experiences and perspectives on the PMTA process and to offer feedback on how FDA can improve efficiency and streamline PMTA reviews.  The topics to be discussed will include certain components of PMTAs such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).

Town Hall – General Wellness: Policy for Low Risk Devices, Final Guidance

Date: Wednesday, Feb. 11, 2026; 1 - 2 p.m. ET

The FDA will host a town hall for industry and other interested parties to discuss updates to the General Wellness: Policy for Low Risk Devices, Final Guidance, issued on January 6, 2026.

Virtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications

Day 1: Wednesday, Feb. 18, 2026; 10:45 a.m. - 4 p.m. ET
Day 2: Thursday, Feb. 19, 2026; 10 - 11:30 a.m. ET and 2 - 3:30 p.m. ET
Day 3: Friday, Feb. 20, 2026; 10 - 11:30 a.m. ET and 2 - 3:30 p.m. ET

The FDA has rescheduled the virtual public meeting on food allergen thresholds and their potential applications in the United States to February 18, 2026, and the listening sessions to February 19-20, 2026.  The FDA will host these events in collaboration with various stakeholders, including industry, consumer groups, healthcare professionals, individual firms, retailers, and academic researchers.  These collaborative efforts will help inform the FDA's next steps, prioritize potential options, and advance our food allergen threshold approaches to benefit public health.

Public Meeting: FDA Rare Disease Day 2026

Date: Monday, Feb. 23, 2026; 9 a.m. - 4 p.m. ET

FDA will host Rare Disease Day, a virtual public meeting, on Monday, February 23, 2026, in global observance of Rare Disease Week.  The theme is: “Moving Forward. Looking Ahead. An Event for Patients.”  The goal of this year’s Rare Disease Day is to explore ways to engage and collaborate with patients and their communities to support and accelerate the development of medical products for rare diseases.  We want patients to connect with FDA and stay involved with our outreach and engagement programs to ensure the patient voice informs medical product development and regulation throughout FDA.

FDA Expert Panel on Food Allergies

Date: Wednesday, Feb. 25, 2026; 1 - 3 p.m. ET

The FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and may offer recommendations for regulatory action.  This initiative is part of the FDA’s broader efforts to apply rigorous, evidence-based standards to modernize regulatory oversight, while considering evolving science and consumer health.  The FDA Expert Panel on Food Allergies will facilitate discussions on the etiology and best treatments for food allergies as well as current health guidelines.

FDA/MHRA/Health Canada Symposium: Regulatory Perspectives in Good Clinical Practice, Bioequivalence and Good Pharmacovigilance Practice

Day 1: Tuesday, June 2, 2026; 8:30 am - 5:15 pm ET
Day 2: Wednesday, June 3, 2026; 8:30 am - 5:15 pm ET
Day 3: Thursday, June 4, 2026; 8:30 am - 5:15 pm ET

This symposium will highlight current and emerging topics of interest to the industry related to good clinical practice, bioequivalence, and good pharmacovigilance practice.  The event will bring together regulators, investigators, clinical researchers, clinical trial staff, sponsors, research organizations, service providers, pharmaceutical and biotechnology companies, academics, and patient advocacy groups.

View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Public 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, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations.  For more information, please contact us at: PublicEngagement@fda.hhs.gov.  For patient specific inquiries, please contact us at: Patients Ask FDA.