January 6, 2025

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. The Public Engagement Staff is responsible for engaging, educating and communicating with external partners including patients, caregivers, health care providers, consumers, academia and trade associations on the agency’s policy priorities. We also recognize the invaluable work of our external partners in achieving these goals. Your partnership, knowledge and engagement in the public health space are appreciated. 

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

• January 6, 2025 - FDA Issues Final Guidance for Industry on Action Levels for Lead in Processed Food Intended for Babies and Young Children
• January 6, 2025 - FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones
• January 3, 2025 - FDA Roundup
• December 30, 2024 - CDRH Unveils Home as a Health Care Hub’s Idea Lab to Help Reimagine How New and Existing Medical Technologies Can Be Incorporated Into the Home
• December 30, 2024 - Update on Ongoing Work to Ensure Continued Effectiveness of the Federal-State Milk Safety System
• December 30, 2024 – FDA Issues Uniform Compliance Date for Food Labeling Regulations Published from January 1, 2025 to December 31, 2026
• December 30, 2024 - 7 Things to Know About How You Can Find CDER’s Drug Safety Information
• December 27, 2024 - FDA Roundup
• December 26, 2024 - FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
• December 26, 2024 - FDA Recommends Changes to Labeling for Transmucosal Buprenorphine Products Indicated to Treat Opioid Use Disorder
• December 23, 2024 - FDA Issues Final Rule to Broaden Types of Nonprescription Drugs Available to Consumers
  
• December 23, 2024 - FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
• December 20, 2024 - FDA Approves Drug to Prevent or Reduce the Frequency of Bleeding Episodes for Patients with Hemophilia A with Inhibitors or Hemophilia B with Inhibitors
• December 18, 2024 - FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Oysters from British Columbia, Canada Growing Areas BC 14-8 and BC 14-15, Potentially Contaminated with Norovirus
• December 17, 2024 - FDA and USDA Announce Charter to Clarify Jurisdiction for Animal Biologicals
• December 17, 2024 - FDA Announces European Union (EU) Requirements for All Honey and Other Apiculture Products Imported into the EU

Consumer Updates

How to Buy Medicines Safely From an Online Pharmacy

Have you ever been tempted to buy your medicines from an online pharmacy or another website?
You can protect yourself and your family by being cautious when buying medicine online. Some pharmacy websites operate legally and offer convenience, privacy, cost savings and safeguards for purchasing medicines.

The Facts on Tampons—and How to Use Them Safely

If you use tampons during your period (or menstruation), it’s important to know how to use them safely. Consider this important information from the U.S. Food and Drug Administration — and please share this information with other people who may use these products.

Guidance Documents

Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies

Considerations for Complying with 21 CFR 211.110

Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices

M15 General Principles for Model-Informed Drug Development

E6(R3) Good Clinical Practice: Annex 2

E11A Pediatric Extrapolation

Advanced Manufacturing Technologies Designation Program

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!

A Fresh Take on What "Healthy" Means on Food Packages

With so many food options out there, it is helpful to have information on food packages that can empower you to identify healthier choices.

To help consumers identify foods that are particularly useful in building healthy dietary patterns, the FDA has updated the definition of the “healthy” nutrient content claim, which includes criteria a food must meet to use the “healthy” claim on the package. The FDA also is exploring the development of a symbol to represent the claim “healthy” to make it easier to spot foods that can be the foundation of healthy eating patterns.

Webinars and Virtual Workshops

Optimizing the Assessment of Cancer Treatment Tolerability: Examination of Patient-Reported Symptoms & Physical Function

January 21, 2025; 3 - 4 p.m. ET

This talk will emphasize the importance of measuring tolerability in cancer clinical trials, highlighting key patient-reported outcomes that are integral to the assessment of treatment tolerability. The presentation will focus on patient-reported symptomatic adverse events (AE) and patient-reported physical function, two domains emphasized in the recent FDA Guidance for Industry on Core-Patient Reported Outcomes in Cancer Clinical Trials.

RegenMedEd Roundtable with FDA’s Office of Therapeutic Products (OTP)

January 30, 2025; 1 - 2 p.m. ET

During the webinar, OTP’s Super Office Director, Dr. Nicole Verdun, and other leaders across OTP will:

• Share how the office has enhanced its capabilities to address the exponential growth in the cell and gene therapy space 
• Provide an update on OTP’s goals, priorities, and activities for 2025
• Engage directly with patients, caregivers, and members of the patient community to provide information about OTP’s patient engagement and outreach efforts

Please note, this webinar is geared toward patients, caregivers, and patient advocates and organizations, however, all are welcome to attend.

Virtual Public Meeting – Food and Drug Administration, Center for Devices and Radiological Health Real-World Evidence Update

January 30, 2025; 11 a.m. - Noon ET

The purpose of this meeting is, in part, to fulfill the Center’s Medical Device User Fee Amendments 2022 (MDUFA V) commitment to update the public on the CDRH’s Real-World Evidence (RWE) program activities.

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.