August 23, 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

• August 22, 2024 - FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
• August 22, 2024 - Update on Ongoing Work to Ensure Continued Effectiveness of the Federal-State Milk Safety System
• August 21, 2024 - Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones & Gummies (June 2024)
•  August 20, 2024 - FDA Roundup
• August 20, 2024 - FDA to Hold Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food
• August 16, 2024 - FDA Roundup
• August 14, 2024 - 9 Things to Know About CDER’s Efforts on Rare Diseases

Spotlight!

New Request for Applications for FDA Rare Neurodegenerative Disease Grant Program

FDA announced a new funding opportunity for the FDA Rare Neurodegenerative Disease Grant Program to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare neurodegenerative diseases for children and adults. Applications are due October 22, 2024.

Consumer Updates

It’s a Good Time to Get Your Flu Vaccine

Influenza (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.

Eating Too Much Salt? Ways to Cut Back...Gradually

Did you know that “salt” and “sodium” are not the same thing, even though they’re often used interchangeably? Sodium, a mineral, is one of the elements found in salt. Salt is where most of your sodium comes from.

Guidance Documents

Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide

FDA has developed this Small Entity Compliance Guide to explain the actions a small entity is required to take to comply with the MQSA rule and its implementing regulations. The March 2023 MQSA rule modernized mammography regulations and specifies that the mammography report given to patients specifies if the patient has dense or non dense breast tissue and includes a prescribed paragraph on the significance of breast density.

Electronic Submission Template for Medical Device De Novo Requests

This guidance provides the standards for the submission of De Novo Requests by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement.

FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

The purpose of this guidance is to establish procedures for submitting, reviewing, and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that are submitted in accordance with section 513(g) of the FD&C Act.

Predetermined Change Control Plans for Medical Devices

FDA is issuing this draft guidance to propose a policy for Predetermined Change Control Plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device.

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

This guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA, or an applicant that has submitted to FDA, an abbreviated new drug application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act).

Acceptable Media for Electronic Product User Manuals

FDA is issuing this guidance to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This is done to recognize that electronic media are now being widely used to provide instruction, while at the same time reducing paper consumption, increasing accessibility and providing rapid means for editing and updating content.

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!

Updates on Highly Pathogenic Avian Influenza (HPAI)

Highly Pathogenic Avian Influenza (HPAI) is a disease that is highly contagious and often deadly in poultry, caused by highly pathogenic avian influenza A (H5) and A (H7) viruses; it is also known as bird or avian flu. HPAI viruses can be transmitted by wild birds to domestic poultry and other bird and animal species. Although bird flu viruses do not normally infect humans, sporadic human infections have occurred. It is important to note that “highly pathogenic” refers to severe impact in birds, not necessarily in humans.

Webinars and Virtual Workshops

ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients

September 6, 2024; 9 a.m. - 5 p.m. ET

FDA in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI) is convening this one-day workshop to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in pediatric clinical studies, and encouraging pediatric clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups, where appropriate and other topics.

Conversations on Cancer: National Hispanic Family Cancer Awareness Week

September 20, 2024; 11 a.m. - 12 p.m. ET

The FDA Oncology Center of Excellence Project Community will hold its inaugural National Hispanic Family Cancer Awareness Week, from September 20 through 26, 2024. The week will feature a Conversation on Cancer public panel discussion on September 20, and a social media campaign throughout the week, using the hashtag #LatinePuede!

Meeting 1: Patient and Care Partner Perspectives on Safety Considerations for Approved Gene Therapy Treatments for Rare Diseases

September 20, 2024; 11 a.m. - 4:30 p.m. ET

The FDA Center for Biologics Evaluation and Research (CBER) is hosting a public patient listening meeting and opening a docket to better understand patient and care partner perspectives on safety considerations and long-term follow-up for approved gene therapy treatments for rare diseases.

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.