October 21, 2024

Dear Public Engagement 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,

The Public Engagement Staff
Public Engagement Staff | FDA

Updates

• October 18, 2024 - Fact Sheet: HHS Continues Taking Action to Increase Access and Supply of IV Fluids Following Hurricane Helene
• October 18, 2024 - FDA Roundup 
• October 18, 2024 - FDA approves zolbetuximab-clzb with chemotherapy for gastric or gastroesophageal junction adenocarcinoma
• October 17, 2024 - Youth Tobacco Product Use at a 25-Year Low, Yet Disparities Persist 
• October 16, 2024 - FDA Releases Updated Biosimilar Curriculum Toolkit
• October 15, 2024 - FDA Roundup
• October 15, 2024 - 7 Things to Know About Drug Shortage Management
• October 15, 2024 - Electronic Medical Devices, X-ray Imaging and Radiation Therapy; What to Know and How to Prevent Disease
• October 15, 2024 - Accelerating Rare Disease Cures (ARC) Program
• October 15, 2024 - Device Trial Participation Snapshots
• October 15, 2024 - NIH and FDA leaders call for innovation in development of smoking cessation treatments
• October 15, 2024 - FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine
• October 11, 2024 - FDA Roundup
• October 11, 2024 - FDA Approves New Treatment for Hemophilia A or B
• October 11, 2024 - Recording Available for Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food

Spotlight!

FDA in Your Day

In this video Chief Medical Officer, Dr. Hilary Marston, discusses the at-home test options available for respiratory illness.

This week, the FDA continues ongoing efforts to increase access and supply of IV and peritoneal dialysis (PD) fluids following Hurricane Helene-related damage to Baxter International Inc.’s facility in Marion, North Carolina. Specifically, the FDA acted quickly to conduct scientific and regulatory assessments to help facilitate the temporary importation of 23 different IV and PD fluids from five Baxter facilities around the world. These supply improvements, combined with increased output from other manufacturers, should help health care providers get more of the product they need over the coming weeks. For more information and FDA actions, visit the FDA website detailing recovery efforts.

Consumer Updates

It’s a Good Time to Get Your Flu Vaccine

Flu viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated in the fall can lower your chances of getting the flu (influenza).

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

While overall smoking rates have declined over the years, youth tobacco use remains a concern. According to the National Youth Tobacco Survey, in 2024 about 2.25 million youth reported current use of any tobacco product, including more than 1.63 million youth who reported current use of e-cigarettes.

Guidance Documents

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that will be referenced in an abbreviated new drug application (ANDA), or a prior approval supplement (PAS) to an ANDA.

Postoperative Nausea and Vomiting: Developing Drugs for Prevention

This guidance provides recommendations regarding the design of clinical trials for the prevention of postoperative nausea and vomiting in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.

Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method

The purpose of this guidance is to provide recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method.

Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

The purpose of this guidance is to provide a framework for considering whether and what type of long-term neurologic, sensory and developmental evaluations could be useful to support a determination of safety of a drug, biological product, or device (referred to as ‘medical product’ in this guidance) for use in neonates, and if so, which domains of neurodevelopment may be most applicable.

Core Patient-Reported Outcomes in Cancer Clinical Trials

This guidance provides recommendations to sponsors for collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design.

Requests for Reconsideration at the Division Level Under GDUFA

This guidance provides recommendations on the procedures for applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.

CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food 

This guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate labeling that an adult maintenance cat food supports urinary tract health by promoting a healthy mineral content in the urinary tract.

Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway

This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for endosseous dental implants and abutments in the Safety and Performance Based Pathway.

Temporary Policies for Compounding Certain Parenteral Drug Products

The FDA is announcing the availability of a final guidance for industry entitled “Temporary Policies for Compounding Certain Parenteral Drug Products.”  As of October 10, 2024, pursuant to section 319(a) of the Public Health Service Act (PHS Act), Department of Health and Human Services (HHS) Secretary Becerra has determined that public health emergencies (PHEs) exist as a result of the consequences of Hurricane Helene in the States of North Carolina, Florida, Georgia, Tennessee, and South Carolina, and as a result of the consequences of Hurricane Milton in the State of Florida.

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!

Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub | Reagan-Udall Foundation

The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Disease Innovation Hub, hosted a public meeting on October 16, 2024. The meeting brought together rare disease patient advocates, academic researchers, regulated industry, and other key stakeholders to discuss how the recently announced Rare Disease Innovation Hub can best engage with members of the rare disease community and prioritize its work.

Below is a link to the Federal Register Notice where you can submit comments until October 31^st. 
https://public-inspection.federalregister.gov/2024-17924.pdf

Webinars and Virtual Workshops

FDA Drug Topics: Cannabis Products and the Potential Impact on Patients

October 29, 2024

1 p.m. – 2 p.m. ET

This educational webinar is designed to aid physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and students, to provide better patient care by knowing how to find relevant FDA regulatory information that will improve drug safety. This webinar will provide insights into the landscape of the cannabis marketplace and some general information on how products are manufactured and regulated. It will discuss clinical and pharmacological considerations along with known drug-drug interactions that can impact patients. The presentation will identify common misconceptions on the use and safety of cannabis products and provide attendees with accurate information to help prevent the spread of misinformation. We will provide attendees with a greater knowledge of ways to identify and report adverse events associated with these products to FDA, as well as suggestions on how to create a safe space to discuss patient use of these products.

2024 Scientific Computing and Digital Transformation Symposium

November 4 - 6, 2024

Day 1: Mon, Nov 4; 9 a.m. - 4:30 p.m. ET
Day 2: Tue, Nov 5; 10 a.m. - 4:30 p.m. ET
Day 3: Wed, Nov 6; 9 a.m. - 4:30 p.m. ET

This year, the FDA Scientific Computing Board (SCB) and the Office of Digital Transformation (ODT) have partnered to co-host this event, which advances our strategic goal to ‘Create a Shared OneFDA Ecosystem’ and facilitates stakeholder engagement and knowledge sharing.

FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference

November 6 - 7, 2024

Day 1: Wed, Nov 6; 8 a.m. - 5 p.m. ET
Day 2: Thu, Nov 7; 8 a.m. - 4 p.m. ET

This two-day conference is intended to share information among FDA representatives and the regulated community, to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the research professional’s product development experience.

Public Workshop –Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices

November 6, 2024; 8 a.m. - 5 p.m. ET

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The purpose of this public workshop is for the FDA to discuss with stakeholders the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to support biocompatibility of medical devices.

Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products

November 6 - 7, 2024

Day 1; Wed, Nov 6; 8:30 a.m. - 5:30 p.m. ET
Day 2; Thu, Nov 7; 8:30 a.m. - 5:30 p.m. ET

This interactive two-day workshop will discuss the regulatory recommendations on confirmatory testing methods for the formation of Nitrosamine Drug Substance Related Impurities (NDSRIs) , safety testing methods for NDSRIs, and recommended acceptable intake limits for NDSRIs.

16th Annual Sentinel Initiative Public Workshop

November 7, 2024; 9 a.m. - 4:15 p.m. ET

The FDA, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 7, 2024, at the National Press Club in Washington, D.C.

Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation

November 7, 2024; 1 p.m. - 2:30 p.m. ET

This webinar aims to inform stakeholders, particularly those who design, implement and assess risk evaluation and mitigation strategies (REMS), on the recently published guidance REMS Logic Model: A Framework to Link Program Design With Assessment.

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.