June 29, 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:

• Notification on Data Integrity
• Recall Update: Instructions for Abiomed Automated Impella Controllers

Updates

• June 26, 2026 - FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health
• June 24, 2026 - FDA Approves First Treatment Shown to Reduce the Risk of Acute Pancreatitis in Adults with Severe Hypertriglyceridemia
• June 24, 2026 - FDA Approves Sacituzumab Govitecan-hziy as Monotherapy and in Combination with Pembrolizumab for First-line Treatment of Triple-Negative Breast Cancer
• June 24, 2026 - Drug Trials Snapshots
• June 24, 2026 - FDA Approves Palbociclib with Trastuzumab, with or without Pertuzumab, and Endocrine Therapy for the Maintenance Treatment of HR-positive, HER2-positive Metastatic Breast Cancer
• June 24, 2026 - FDA Advances Post-Market Review of Phthalates Used in Food Contact Materials
• June 23, 2026 - National Youth Tobacco Survey: FDA Publishes Peer-Reviewed Journal Article, Releases 2025 Findings
• June 22, 2026 - Phase 1 Investigational New Drug (IND) Navigator

Spotlight

FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development

The U.S. Food and Drug Administration (FDA) is announcing actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials.  The FDA’s work is outlined in Operation TrialBlazer, a U.S. Department of Health and Human Services (HHS) initiative.

Consumer Updates

Help the FDA Prevent the Sale of Tobacco Products to Young People

While youth tobacco use has reached historic lows, any youth tobacco use remains a concern.  According to the National Youth Tobacco Survey, in 2025 about 2.01 million youth reported current use of any tobacco product, including more than 1.44 million youth who reported current use of e-cigarettes.  Many teens underestimate how easy it is to become addicted to the nicotine in tobacco products.  Nicotine use is particularly concerning in young people because they are at increased risk of nicotine addiction, as their brains are still undergoing critical development.  Cigarette use can also lead to other harmful health effects like decreased lung growth and function, and heart disease.

Guidance Documents

• Master Protocols for Drug and Biological Product Development
• Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
• Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
• CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations

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

FDA Oncology Center of Excellence Presents Conversations on Cancer: Religious Literacy and Spiritual Care for Patients and Caregivers

Date: Wednesday, July 1, 2026; 2 - 3 p.m. ET

Research shows that spiritual care for cancer patients remains an unmet need.  During this discussion, the panel will explore the differences between religion and spirituality and how increasing religious literacy and spiritual care may impact overall patient care.

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

ICYMI!

FDA and NIH are co-sponsoring a free Population Assessment of Tobacco and Health (PATH) Study Data User Workshop in sessions on August 11-12 and September 17-18 for academic faculty, researchers, and graduate students.  Both sessions cover the same material, and applicants should select the session that best fits their schedule when applying.

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.