September 27, 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

• September 26, 2024 - Ongoing Work to Ensure Continued Effectiveness of the Federal-State Milk Safety System
• September 26, 2024 - FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns
• September 26, 2024 - The FDA Updates Mycotoxins in Domestic and Imported Human Foods Compliance Program
• September 26, 2024 - Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products
• September 26, 2024 - FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
• September 25, 2024 - Live Biotherapeutic Products To Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants; Public Workshop; Request for Comments
• September 25, 2024 - FDA Awards Funds for Three Projects to Collect, Analyze and Report Data on Antimicrobial Use in Animals
• September 24, 2024 - FDA Approves New Drug to Treat Niemann-Pick Disease, Type C
• September 24, 2024 - FDA Roundup
• September 23, 2024 - FDA Issues Updated Small Entity Compliance Guide for Produce Safety Regulation
• September 20, 2024 - FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration
• September 20, 2024 - FDA Roundup

Spotlight!

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. The panel discussion takes place October 23, 2024, from 2:00 pm to 3:00 pm ET and will focus on Dr. Pazdur’s unceasing and continuing service to the global oncology community.  During his 25 years of oncology leadership at the FDA, Dr. Pazdur has served with seven FDA Commissioners. Register now to watch this unique panel discussion with some of those FDA Commissioners and Dr. Pazdur.

The FDA published a digital health and artificial intelligence glossary as an educational resource to help support consistent use of digital health and artificial intelligence terminology by the FDA and interested parties (such as industry, digital health developers, academia, health care professionals, and patients).

Consumer Updates

Caution: Bodybuilding Products Can Be Risky

Your friends at the gym can’t say enough about the bodybuilding products they’ve been taking to help build muscle mass and strength. You wonder, are they all safe to use?

Guidance Documents

Small Entity Compliance Guide: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

The produce safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.

An Acceptable Circular of Information for the Use of Human Blood and Blood Components

The June 2024 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion.

Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program

This guidance provides information regarding how basic safety and essential performance standards are incorporated into the Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Program).

The Accreditation Scheme for Conformity Assessment (ASCA) Program

The FDA was directed to issue a guidance regarding the goals and implementation of the ASCA Program in a pilot phase. FDA is concluding the ASCA pilot phase and establishing an ongoing ASCA Program, in accordance with amendments made to section 514 by section 2005 of the FDA User Fee Reauthorization Act of 2022, part of the Medical Device User Fee Amendments of 2022 (MDUFA V). The establishment of the goals, scope, procedures, and a suitable framework for the voluntary ASCA Program supports the Agency’s continued efforts to use its scientific resources effectively and efficiently to protect and promote public health.

Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program

This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Program).

Chemical Analysis for Biocompatibility Assessment of Medical Devices

This draft guidance document provides the FDA’s recommendations on analytical chemistry testing to assess the biocompatibility of medical devices. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. This guidance applies to methods for analytical chemistry testing of medical devices generally.

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!

FDA in Your Day

Vaccines are the best way to protect yourself from getting certain diseases. But some people worry that some vaccines – like RSV and COVID-19 – are ‘just too new.’ While it’s natural to think about this, it's the FDA's job to determine their safety and effectiveness before they can be used in the U.S. and before your health care provider recommends them.

The Facts on Tampons—and How to Use Them Safely

If you use tampons during your period (or menstruation), it’s important to know how to use them safely. Consider this important information from the U.S. Food and Drug Administration — and please share this information with other people who may use these products.

Webinars and Virtual Workshops

Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products

October 7 - 8, 2024

Day 1: Mon, Oct 7; 8:30 a.m. - 5:35 p.m. ET
Day 2: Tue, Oct 8; 8:30 a.m. - 5:10 p.m. ET

The purpose of this workshop is to engage with industry, academia, and FDA in a discussion on the scientific and regulatory challenges associated with immunogenicity risk assessment for proposed generic peptide and oligonucleotide drug products.

Webinar - The Voluntary Improvement Program: How to Enroll, Opportunities, and Best Practices

October 8, 2024; 1 - 2 p.m. ET

During this webinar, the FDA will:

• Discuss the VIP enrollment and participation criteria for manufacturing sites,
• Review the value, expectations, and regulatory opportunities for participants,
• Share best practices for submitting a 30-Day Notice, and
• Answer questions from webinar participants about the VIP.

Registration is not required.

ICH M12 Drug-Drug Interaction Studies Final Guidance

October 9, 2024; 1 - 3 p.m. ET

This webinar will discuss the ICH M12 Drug Interaction Studies guidance which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. The guidance describes a systemic approach to evaluation of the drug interaction potential of investigational drugs during drug development and regulatory review.

FDA and NIH Joint Public Meeting on Advancing Smoking Cessation Priorities

October 21, 2024; 9 a.m. - 4:30 p.m. ET

The FDA  and the National Institutes of Health (NIH) will host a joint public meeting entitled, “Advancing Smoking Cessation: FDA and NIH Priorities”. The focus of the meeting is on advancing innovation of smoking cessation products to help both adults and youth. 

The meeting will feature presentations and panel discussions on several smoking cessation-focused topics, including:

• Clinical and community perspectives
• Promising target areas for development
• Regulatory paths forward

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

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

The FDA, the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) are announcing a public workshop entitled “Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants.” 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.

View Upcoming FDA Meetings, Conferences and Workshops

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

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.