August 9, 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 9, 2024 - FDA Approves First Nasal Spray for Treatment of Anaphylaxis
• August 7, 2024 - FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose
• August 6, 2024 - FDA Roundup

Spotlight!

The FDA announced the release of the new FDA Language Access Plan 2024, which supports the U.S. Department of Health and Human Services’ (HHS) Language Access Plan, released in November of 2023. The HHS Language Access plan was updated for the first time since 2013, in an effort to “ensure greater access to the life-saving services that it provides for people with Limited English Proficiency (LEP) and people with disabilities.”

Guidance Documents

CVM GFI #293 - FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients

This guidance describes our policy that FDA generally does not intend to initiate enforcement action with respect to the food additive approval requirements of the FD&C Act for the ingredient, or animal food containing the ingredient, that is listed in the Official Common or Usual Names and Definitions of Feed Ingredients section of chapter six of the AAFCO 2024 OP.

CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)

The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority to regulate substances used in animal food, including substances that are food additives and substances that are generally recognized as safe (GRAS) for their intended uses in food. This guidance describes FDA’s enforcement policy for certain ingredients assessed using the AFIC process.

Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment

This guidance provides recommendations for the development of drug and biological products for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC). This guidance discusses pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints.

Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases

This guidance is intended to assist sponsors in identifying an optimized dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development prior to submitting an application for approval for a new indication and usage. This guidance does not address selection of the starting dosage for first-in-human trials.

View all Official FDA Guidance Documents and other Regulatory Guidance
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ICYMI!

FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients

An estimated 10,000+ rare diseases affect more than 30 million people – approximately one out of every 10 people – in the U.S., and about half of these people are children. Many rare conditions are life threatening, and most do not have approved treatments. Fundamental to the mission of the FDA is to engage patients and caregivers – to understand their unique perspectives and experiences and keep these front of mind as we review medical products for rare disease patients.

Webinars and Virtual Workshops

FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA

September 4, 2024; 11:00 a.m. - 3:00 p.m. ET

The webinar aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. This activity is intended to provide an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics.

2024 Center for Biologics Evaluation and Research (CBER) Science Symposium

September 16-18, 2024; 9:30 a.m. - 4:00 p.m.

The purpose of the public symposium is to discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision making, and to provide a forum for developing collaborations within FDA and with external organizations. The symposium will include presentations by experts from academic institutions, government agencies and research institutions.

FDA to Hold Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food

September 25, 2024; 12:30 p.m. - 4:30 p.m. ET

The purpose of this meeting is for FDA to share information about the development of FDA’s enhanced systematic process for post-market assessment of chemicals in food including considerations for identifying and prioritizing food chemicals currently in the market for safety reviews. During the event, there will also be presentations from stakeholders as they share their perspectives on this topic.

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.