September 14, 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:

• Glutathione, Myer’s Cocktail, and Tri-Immune Boost by Centric Compounding

Updates

• Sept. 11, 2026 - Post-Outbreak Response Activities: Multistate Outbreaks of Cyclospora Illnesses
• Sept. 11, 2026 - FDA Approves First Therapy to Target Muscle Loss in Spinal Muscular Atrophy
• Sept. 11, 2026 - Patient Voice in Rare Disease Medical Product Development
• Sept. 10, 2026 - CDRH Rare Disease Impact Initiative
• Sept. 10, 2026 - Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes
• Sept. 9, 2026 - Outbreak Investigation of Salmonella: Sprouts (September 2026)
• Sept. 9, 2026 - FDA Clarifies It Does Not Provide Certificates or Other Documents to Verify Compliance for Cosmetic Product Facility Registration
• Sept. 9, 2026 - FDA Grants Accelerated Approval to Sevabertinib for Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
• Sept. 9, 2026 - FDA Provides Information for Consumers Considering Clear Dental Aligners 
• Sept. 8, 2026 - HHS Announces Key Leadership Selections at FDA to Promote Innovation, Reform, and National Health Priorities

Spotlight

FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing

Consumer Updates

Braces Have Changed: What to Know about Traditional Braces and Clear Aligner Options

Should You Put Sunscreen on Infants?  Not Usually

When you go outdoors with your infant, whether for a quick stroll in the park or a day at the beach, it’s important to keep your little one out of the sun.  But should you put sunscreen on your baby to protect them from the sun’s bright rays?  Not usually.  Your infant’s sensitive skin is vulnerable to serious burns.  But sunscreen isn’t the answer, according to the FDA.  That’s because infants are at greater risk than adults of sunscreen side effects, such as a rash.

Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses

Sun safety is always in season.  It’s important to protect your skin from sun damage throughout the year, no matter what the weather.  Exposing your skin to the sun year-round means you are exposing it to ultraviolet radiation, which can cause sunburn, early skin aging (such as skin spots, wrinkles, or “leathery skin”), eye damage, and skin cancer, the most common form of cancer in the U.S.  Sunscreen is one of several ways to help reduce the risk of skin cancer.

Guidance Documents

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 Workshops

2026 PDA/FDA Joint Regulatory Conference

Day 1: Monday, Sept. 14, 2026; 7 a.m. - 6 p.m. ET
Day 2: Tuesday, Sept. 15, 2026; 7 a.m. - 6 p.m. ET
Day 3: Wednesday, Sept. 16, 2026; 7 a.m. - 3:30 p.m. ET

FDA and Parenteral Drug Association (PDA) will host the 2026 PDA/FDA Joint Regulatory Conference, Excellence in CGMP: Ensuring Quality, Protecting Patients, in Washington, D.C.  The conference will offer practical insights on current good manufacturing practice (CGMP) compliance, quality systems, risk-based manufacturing, supply chain oversight, and industrial modernization through expert-led discussions and real-world case studies.  The conference will explore regulatory priorities, emerging technologies, and quality challenges through expert-led discussions, case studies, and direct engagement with regulators and industry leaders.

Considerations for Potential Future Therapeutic Use of Psychedelic Drugs Public Hearing

Date: Monday, Sept. 14, 2026; 12:30 - 4:30 p.m. ET

The FDA is announcing a public hearing, held in collaboration with federal partners, to obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings.

Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA)

Date: Wednesday, Sept. 16, 2026; 9 a.m. - 2 p.m. ET

The FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032.

Pediatric Advisory Committee Meeting Announcement

Date: Wednesday, Sept. 16, 2026; 10 a.m. - 4 p.m. ET

The PAC will have the opportunity to ask the Agency clarifying questions and to convey their recommendations for safety monitoring of the products listed below.  The scope of the discussion will be limited to post-marketing safety and surveillance activities.

Collaborating on Food Safety Culture: Food Safety Culture: So What?  Moving Beyond Compliance to Impact

Date: Wednesday, Sept. 16, 2026; noon ET (Webinar 8)

The webinar series engages experts from the public and private sectors in a collaborative exchange of ideas and experiences related to the importance of a robust food safety culture in helping to ensure safe food production.  The series will have valuable information for both those well-versed on, and those just learning about, food safety culture.

Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)

Date: Thursday, Sept. 17, 2026; 9 a.m. - 2 p.m. ET

FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2028 through 2032.

FDA Public Meeting: Testosterone Use In Menopausal Women

Date: Thursday, Sept. 17, 2026; 9 a.m. - 4:30 p.m. ET

The purpose of the workshop is to examine the current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women to help inform future research and potential drug development in this area.

Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

ICYMI!

The FDA announces the Advancing Real-World Evidence (RWE) Program submission deadline as Sept. 30, 2026.

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.