December 16, 2024

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. The Public Engagement Staff is responsible for engaging, educating and communicating with external partners including patients, caregivers, health care providers, consumers, academia and trade associations on the agency’s policy priorities. We also recognize the invaluable work of our external partners in achieving these goals. Your partnership, knowledge and engagement in the public health space are appreciated. 

Sincerely,
Public Engagement Staff | FDA

Updates

• December 16, 2024 - FDA and Stop Foodborne Illness to Co-Host Upcoming Food Safety Culture Webinar Series
• December 13, 2024 - FDA Revokes EUAs for Four Monoclonal Antibody Products
• December 13, 2024 - FDA Approves New Treatment for Congenital Adrenal Hyperplasia
• December 13, 2024 - FDA Roundup
• December 13, 2024 - Release of Annual Report for 2022 on the Sources of Foodborne Illness by the Interagency Food Safety Analytics Collaboration
• December 12, 2024 - Serious Liver Injury Being Observed in Patients without Cirrhosis Taking Ocaliva (obeticholic acid) to Treat Primary Biliary Cholangitis
• December 12, 2024 - CDER Center for Real-World Evidence Innovation (CCRI)
• December 12, 2024 - FDA Issues Letter to Retailers and Distributors Concerning Lead in Certain Imported Cookware
• December 11, 2024 - Patient Engagement Collaborative Announces Eight New Members
• December 10, 2024 - VQIP Application Portal Opens for FY2026
• December 10, 2024 - FDA Roundup

Spotlight!

FDA’s Role In Managing Drug Shortages | FDA In Your Day Ep. 18

You may have heard about drug shortages in the news, or from a family member or friend. While the FDA can't eliminate drug shortages on our own, we can help lessen their impact on patient care.

Consumer Updates

Skip the Antibacterial Soap; Use Plain Soap and Water

When you buy soaps and body washes, do you reach for products labeled “antibacterial” hoping they’ll keep your family safer? Do you think those products will lower your risk of getting sick, spreading germs or being infected?
According to the FDA currently there isn’t sufficient evidence to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water.

Guidance Documents

Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products

Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

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.

ICYMI!

Patient Engagement Collaborative

The Patient Engagement Collaborative (PEC) is a joint project between the FDA and the Clinical Trials Transformation Initiative (CTTI). The PEC is an ongoing, shared setting in which the patient community (PEC members), FDA, and CTTI discuss many topics for improving communication, education, and patient engagement related to medical product regulation.

Webinars and Virtual Workshops

OCE Conversations on Cancer, Cervical Cancer Treatment Innovation: A Collaborative Discussion

January 14, 2025; 10 - 11 a.m. ET

Join us for an engaging discussion that will bring together key stakeholders in the fight against cervical cancer, including representatives from the patient advocacy community, academia, community oncology, the EMA and the FDA to discuss the historical path that has led us to the current treatment landscape, the impact of new therapies on individuals with cervical cancer and their families, areas of ongoing high impact research, and what the future might bring.

Registration is not required.

Webinar – Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

January 14, 2025; 2 - 3:15 p.m. ET

This guidance provides recommendations on the information to include in a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more artificial intelligence-enabled device software functions (AI-DSFs). This guidance recommends that a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications.

Registration is not required.

FY25 FDA Broad Agency Announcement Question and Answer Session

January 16, 2025; 1 - 2:30 p.m. ET

FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. FY25 FDA BAA Question and Answer Session will provide an opportunity to the applicants to learn more about the application process. Join us to learn more about the FY25 BAA application process, next steps, and clarify any questions on how to apply.

FDA-AACR Workshop: To Test or Not to Test – That is the Question: DPD Deficiency and Weighing Potential Harms

January 16, 2025; 9 a.m. - 3 p.m. ET

The purpose of this workshop is to provide a multidisciplinary forum to examine the existing information and evidence surrounding DPD deficiency testing, hear about the current clinical approaches to DPD deficiency testing from practicing oncology healthcare providers, and discuss future directions for advancing the field.

BsUFA III Regulatory Science Pilot Program: Progress Update

January 22, 2025; 1 - 3 p.m. ET

The FDA Biosimilar User Fee Act (BsUFA) III Regulatory Science Pilot program is hosting its second virtual event.
The agenda includes a recap of the activities of regulatory science pilot program from the last engagement that occurred on October 16, 2023. Additionally, the webinar will include a status update on the programs current research portfolio as it relates to the BsUFA III commitments as well as presentations and panel discussions by FDA staff. Lastly, FDA staff will present the next steps planned for the BsUFA III regulatory science program.

Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA

January 28 - 29, 2025

Day 1; Tue, Jan 28; 8:30 a.m. - 4 p.m. ET
Day 2; Wed, Jan 29; 8:30 a.m. - 4 p.m. ET

FDA’s Knowledge-aided Assessment and Structured Application (KASA) initiative is a creative regulatory approach for modernizing quality assessment and enhancing submission format. KASA is designed to capture and manage knowledge during the lifecycle of a drug product; establish rules and algorithms to facilitate risk identification, mitigation, and communication; perform computer-aided analyses of applications for a comparison of regulatory standards and quality risk across the repository of approved drug products and facilities; and provide a structured assessment that minimizes text-based narratives and summarization of information provided in applications.

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement

February 5, 2025; 8 a.m. - 5 p.m. ET

The Committees will discuss the findings of the completed ER/LA OA PMRs 3033-1 and 3033-2 (link to Release and Reissue letter: https://www.fda.gov/media/95546/download).

These PMRs are prospective (3033-1) and retrospective (3033-2) epidemiologic studies that examined the serious risks and predictors of misuse, abuse, addiction, and fatal and non-fatal opioid overdose in patients with long-term use of opioid analgesics for management of chronic pain, including patients prescribed ER/LA OAs.

Registration is not required.

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.