October 11, 2024

Dear Public Engagement Colleague,

The FDA continues its efforts in safeguarding the public against potential health risks, through utilizing peer reviewed evidence, and ensuring the safety and efficacy of medical products, we also recognize the invaluable work of our public engagement groups. The Public Engagement Staff will continue to work with our external partners so you can engage with the Office of the Commissioner and other FDA centers on priorities. Your partnership, knowledge and engagement in the public health space are appreciated.

Sincerely,

The Public Engagement Staff

Updates

• October 10, 2024 - CDRH Proposed Guidances for Fiscal Year 2025 (FY2025)
• October 9, 2024 - Hurricane Helene: Baxter's manufacturing recovery in North Carolina
• October 9, 2024 - FDA, CDC, NIH Consensus Statement on Recent Advisory Council Report on Premature Infants and Necrotizing Enterocolitis
• October 9, 2024 - FDA Grants Exemption to Connected Trading Partners
• October 8, 2024 - Federal Court Enters Consent Decree Against Rizo Lopez Foods Inc. Following Multistate Outbreak of Listeriosis Linked to Queso Fresco and Cotija Cheese Products
• October 7, 2024 - FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities
• October 4, 2024 - FDA Roundup
• October 1, 2024 - FDA Introduces Streamlined Complaint Process in New Human Foods Program

Guidances 

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

Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

October 15, 2024; 1 - 2 p.m. ET

When finalized, the guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle is intended to provide recommendations on how patient preferences can be collected and shared with the FDA and be considered in decision-making. The guidance will also outline the types of patient preference studies that can provide reliable scientific evidence.

Registration is not necessary.

Benchmarks for Diversity in Oncology Clinical Trials: An FDA - ACS Hybrid Symposium

October 16, 2024; 8:30 a.m. - 2:45 p.m. ET

The Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and the American Cancer Society (ACS) are co-sponsoring a symposium focusing on setting benchmarks for diversity in oncology clinical trials.

Global IDMP Implementation - Getting Closer to the Goal

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

This webinar will present an overview of the end-to-end testing results for the Global Pharmaceutical Product Identification (PhPID) Service operating model, which generates global PhPIDs for marketed medicinal products. The session will detail the model's readiness for deployment, including its software functionality, interoperability, processes, and business rules.

FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Pazdur + 25—Celebrating a Silver FDA Anniversary”

October 23, 2024; 2 - 3 p.m. ET

Join previous FDA Commissioners and the FDA Oncology Center of Excellence, in recognizing a quarter century of federal government service by OCE Center Director, Dr. Richard Pazdur. The esteemed panel will highlight the many oncology advances and changes at FDA throughout Dr. Pazdur’s tenure.

Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants

October 25, 2024; 9 a.m. - 4 p.m. ET

The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with use of live biotherapeutic products to prevent necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.

Finding Your Support Team While Participating in a Clinical Trial

October 30, 2024; Noon - 1:15 p.m. ET

The webinar will feature a panel of patients, care partners, and advocates discussing the following:

• Experiences with their own support systems as they or a loved one participated in a clinical trial.
• Tips on how to navigate logistical challenges, such as travel, when participating in a clinical trial.
• Where and how to find support from friends and family, health care providers, clinical teams, employers, schools, patient advocacy groups, and other communities.

Informed Consent – More than Just Another Document to Sign?

November 8, 2024; 2 - 3 p.m. ET

This webinar will provide patients and researchers with an overview of FDA’s expectations for informed consent.
The webinar will:

• Give an update on FDA’s efforts to help improve informed consent materials so that they are more understandable for participants;
• Recommend how informed consent can be presented in a clear, comprehensible way; and
• Discuss how revised consent can help individuals make an informed decision on whether to join a clinical trial.

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.