May 11, 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

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:

• Boston Scientific Issues Correction for ACCOLADE Pacemakers and CRT-Ps
• Disruptions in Availability of Neurosurgical Patties & Sponges

Updates

• May 8, 2026 - FDA Grants Seventh Approval under the National Priority Voucher Pilot Program
• May 8, 2026 - FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics
• May 6, 2026 - FDA Approves First Drug to Treat Noise Aversion and Separation Anxiety in Dogs
• May 6, 2026 - FDA Expands AI Capabilities and Completes Data Platform Consolidation
• May 6, 2026 - FDA Grants 22^nd Commissioner's National Priority Voucher to Drug Treatment for Ultra-Rare Bile Duct Cancer
• May 6, 2026 - FDA Posts Summary on Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications
• May 5, 2026 - FDA Expands Market Access, Authorizes New ENDS Products
• May 4, 2026 - Infant Formulas Marketed in the U.S.

Spotlight

Infant formula is an important source of nutrition for many babies in the U.S., whether used exclusively or in combination with breastfeeding.  Although breastfeeding is recommended as the optimal choice of nutrition for most infants, many infants in the U.S. rely on infant formula for some or all of their nutrition.  Ensuring that the youngest and most vulnerable individuals have access to safe and nutritionally adequate infant formula is a top priority for FDA.

Consumer Updates

Is It Really 'FDA Approved'?

“FDA approved!”  Maybe you saw those words on a company’s website or in an ad promoting a product or treatment.  Some marketers may say their products are “FDA approved.”  How can you know for sure what the U.S. Food and Drug Administration has approved?  The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.

FDA Voices

How FDA is Implementing Landmark Cosmetics Legislation to Positively Impact Public Health

By: Steven Kozlowski, M.D., Chief Scientist

Guidance Documents

• Pulmonary Tuberculosis: Developing Drugs for Treatment
• Postapproval Pregnancy Safety Studies
• Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention
• Patient-Matched Guides for Orthopedic Implants
• Submitting Continuous Glucose Monitoring Data in Clinical Trials
• Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application

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

Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma

Date: Tuesday, May 12, 2026; 9:00 a.m. - 2:00 p.m. ET

This webinar is intended to provide blood establishments and other stakeholders with an overview of OBRR’s approach to the review of biologics license applications for the manufacture of blood and blood components, including Source Plasma.  In this event, OBRR staff will give presentations on select topics and address questions submitted by registrants.

Navigate Food Labels with Confidence: Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims

Date: Wednesday, May 13, 2026; noon - 1:30 p.m. ET

The FDA’s Office of Women’s Health, in partnership with the FDA’s Human Foods Program, is hosting a webinar during National Women's Health Week focused on empowering women to make informed, healthy food choices through understanding nutrition labeling and food claims.  This comprehensive session will guide participants through the essential components of the Nutrition Facts Label, teaching them how to use serving sizes and daily values to quickly identify healthier options.  The webinar will also explain the different types of nutrition claims, including but not limited to, health claims and nutrient content claims that may appear on food and supplement labels.  In addition, it will discuss how FDA authorizes these claims to ensure they meet regulatory standards.

FDA Grand Rounds – Pharmacovigilance in Practice: From Safety Signals to Regulatory Action

Date: Thursday, May 14, 2026; noon - 1:00 p.m.

This lecture will discuss the Division of Pharmacovigilance’s drug safety activities within the FDA's Center for Drug Evaluation and Research.  The lecture will focus on how the FDA identifies, evaluates, and responds to postmarket safety concerns and includes three recent safety findings that resulted in regulatory actions.

FDA Industry Information Session Real-Time Clinical Trials RFI

Date: Friday, May 15, 2026; 11:00 a.m. - 1:00 p.m. ET

The U.S. FDA will be taking industry questions on its Request for Information (RFI) soliciting input on a proposed pilot program to assess how artificial intelligence-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials.

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.