March 31, 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. Your partnership, knowledge and engagement in the public health space are appreciated. 

Sincerely,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

• March 28, 2025 - FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors
• March 28, 2025 - FDA Roundup
• March 28, 2025 - FDA Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea and Trichomoniasis
• March 21, 2025 - FDA Roundup
• March 20, 2025 - HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods

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:

• Tec Italy Totale Shampoo by Henkel Capital S.A. de C.V.: Recall - Due to Potential Health Risk
• Endotracheal Tube Recall: Smiths Medical Removes ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation 
• Infusion Pump Software Correction: Becton, Dickinson and Company (BD) Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load

Consumer Updates

Pulse Oximeter Basics

A pulse oximeter, or pulse ox, is a device that estimates the amount of oxygen in the blood. Here’s what to know before using one.

We need oxygen to survive. Sometimes the amount of oxygen in the blood falls too low for the body to function well. Asthma, lung cancer, chronic obstructive pulmonary disease, the flu, and heart disease are among the health conditions that can cause oxygen levels to drop. Being at higher altitudes, where the amount of oxygen in the air can be less than at sea level, can be another factor that can cause oxygen levels to drop.

Guidance Documents

Study Data Technical Conformance Guide - Technical Specifications Document

Data Standards Catalog

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

Generic Drugs Forum (GDF) 2025

April 9 - 10, 2025

Day 1: Wed, Apr 9; 8:30 a.m. - 5:00 p.m. ET
Day 2: Thu, Apr 10; 8:30 a.m. - 5:00 p.m. ET

Join us at the annual Generic Drugs Forum, a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance. Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles.

Updated “Healthy” Claim Webinar Rescheduled

Date: Thu, Apr 10; 1:00 - 2:00 p.m. ET

The FDA invites the public to register for a webinar on the FDA Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” Final Rule. The purpose of this webinar is to provide an overview of the final rule and answer pre-submitted questions. The webinar is open to new registrants, but you do not need to re-register if you previously signed-up for this event.  A separate communication will be sent to anyone previously registered to confirm their event registration and the new event date and time.

Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration - Workshop

April 29 - 30, 2025

Day 1: Tue, Apr 29; 8:30 a.m. - 5:30 p.m. ET
Day 2: Wed, Apr 30; 8:30 a.m. - 3:30 p.m. ET

The In Vitro Permeation Test (IVPT) is an important performance test used by the generic drug industry to support demonstrations of bioequivalence for generic topical drug products, when utilizing efficient characterization-based bioequivalence approaches. The workshop will clarify the intent of FDA recommendations for IVPT studies, with step-by-step demonstrations illustrating how IVPT study procedures can be performed in a manner compatible with recommendations in FDA’s Guidance for Industry.

Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act

Date: May 15, 2025; 9:00 a.m. - 4:30 p.m. ET

The purpose of this public meeting is to seek input from interested parties including, patient/parent/caregiver groups, consumer groups, regulated industry, academia, and others. This input will enable FDA to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, including pediatric drug and biologic development and labeling, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).

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.