April 19, 2024

Dear Colleague,

While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.

Updates

• April 18, 2024 - Patient Medication Information: A 2023 Proposed Rule to Help Patients Understand Their Prescription Medication Information
• April 18, 2024 - FDA Approves Imaging Drug to Assist in Detection of Cancerous Tissue Following Lumpectomy
• April 17, 2024 - Medical Device Safety and Innovation Reports
• April 16, 2024 - FDA Roundup
• April 16, 2024 - Counterfeit Version of Botox Found in Multiple States
• April 15, 2024 - FDA establishes CDER Center for Clinical Trial Innovation (C3TI)
• April 15, 2024 - FDA Announces Funding Opportunity for Meetings on Medical Policy Activities 
• April 12, 2024 - FDA Roundup
• April 12, 2024 - Spotlight on Syphilis and Congenital Syphilis

Spotlight!

The FDA posted a new video in the “FDA In Your Day” series. In this video, Principal Deputy Commissioner Dr. Namandjé Bumpus discusses allergy medicine and food safety.

FDA Voices

Reflections on Travel to Europe – Part One

By: Robert M. Califf, M.D., Commissioner of Food and Drugs

Recently I had the privilege of official travel to the U.K. and European Union (EU) with our extraordinary global affairs team. We visited with The Medicines and Healthcare products Regulatory Agency (MHRA) and representatives of the U.K. medical device, digital and pharmaceutical industries in London and then moved on to Oxford for an exchange and update on the conduct of clinical trials and mutual concerns about cybersecurity. We then traveled to Brussels, where we visited the U.S. Mission to the EU and met with the European Commission (EC), European Food Safety Authority (EFSA), and representatives of European medical products and food industries. Finally, we spent time in Amsterdam meeting with the European Medicines Agency (EMA).

Webinars and Virtual Workshops

FDA Oncology Center of Excellence Presents: Conversations on Cancer: Strength in Numbers, Increasing Cancer Awareness while Decreasing Disparities - 04/23/2024 | FDA

April 23, 2024; 2:30 - 4 p.m. ET

April is National Minority Health Month created to reduce health disparities and raise awareness about improving the health of racial and ethnic minority communities. In March 2023, the White House also proclaimed April as National Cancer Control Month to encourage greater cancer prevention and early detection.  In appreciation of both, FDA/OCE’s Conversation on Cancer series is featuring voices of diverse cancer advocacy groups to lead this month’s public panel discussion entitled, “Strength in Numbers, Increasing Cancer Awareness While Decreasing Disparities”.

Virtual Public Meeting on Data and Technology in the New Era of Smarter Food Safety - 04/24/2024 | FDA

April 24, 2024; 10 a.m. - 4 p.m. ET

The U.S. Food and Drug Administration (FDA) invites the public to register for the virtual public meeting titled “Data and Technology in the New Era of Smarter Food Safety.” The purpose of the public meeting is for FDA and stakeholders to share information and thinking on ways we can leverage data and technology to exponentially advance food safety under the New Era of Smarter Food Safety.

Natural History Studies and Registries in the Development of Rare Disease Treatments

May 13, 2024; 10 a.m. - 3:30 p.m. ET

The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Diseases Team within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine; Office of New Drugs; Center for Drug Evaluation and Research and the National Institutes of Health’s Division of Rare Diseases Research Innovation within the National Center for Advancing Translational Sciences, is hosting a public workshop.

Statistical Considerations for Premarketing Risk Assessment

May 16, 2024; 1 - 2:30 p.m. ET

This presentation will describe important statistical considerations in the premarketing assessment of drug safety. The safety profile of a drug evolves over time through gained experience and increased exposure. The use of diligent planning for safety and rigorous assessment of maturing safety data optimizes the ability to characterize the safety profile of a drug. Learn more here.

View Upcoming FDA Meetings, Conferences and Workshops

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

Guidance Documents

View all Official FDA Guidance Documents and other Regulatory Guidance

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About Us

The Stakeholder 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, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.