Updates
Spotlight!
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FDA Issues Draft Guidance on Patient Focused Drug Development
The FDA issued a draft guidance, “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.” This guidance is the fourth in a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making.
This guidance is intended to help clinical trial sponsors in medical product development. The guidance focuses on clinical outcome assessments (COA) issues associated with clinical trial (study) endpoints, design, conduct and analysis and is most relevant to those designing and conducting trials using COAs as well as analyzing and interpreting the trial data.
On May 4, 2023, FDA is hosting a webinar for patients, industry and other interested stakeholders to discuss and answer questions about the draft guidance.
For more information on the draft guidance and how to submit comments, please see the Federal Register notice.
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Project Community
 Project Community is a public health outreach initiative established by the FDA Oncology Center of Excellence for patients living with cancer, survivors, advocates, families, and people living in underserved urban and rural communities who are at greater cancer risk.
Our goal is to increase communication between the underserved and medical professionals in communities nationwide, to foster understanding, and awareness to reduce cancer risk and increase survival.
FDA Voices
FDA Actions are Reducing Exposure to Contaminants in Our Most Vulnerable Populations
 By: Robert M. Califf, M.D., Commissioner of Food and Drugs
In part 2 of this series on food, I’d like to discuss the part of our mission to help safeguard the food supply that includes the evaluation of the use of chemicals as food ingredients and substances that come into contact with food, and monitoring the food supply for chemical contaminants. The agency takes action when we find that a particular level of a contaminant is associated with a significantly elevated risk of an adverse health effect.
National Minority Health Month: Better Health Through Better Understanding
 By: RDML Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity
After receiving the diagnosis that he was HIV positive at the age of 22, Tony Enso never imagined that he would go on to become one of the first Indigenous performers to open the U.S. Conference on AIDS. Tony’s story is featured as part of the Equity of Voices video series from the FDA’s Office of Minority Health and Health Equity (OMHHE) about individuals living with HIV and finding hope and better health through antiretroviral therapy. “I finally came to the realization I might have HIV for the rest of my life, but I get the rest of my life,” says Tony, a member of the Cherokee tribe and one of seven people featured in the series.
EQUITY of Voices is one of the three aims of OMHHE’s Enhance Equity Initiative, which highlights research projects and communication resources to advance EQUITY in Clinical Trials, and EQUITABLE data efforts, in addition to Equity of Voices. As the FDA observes National Minority Health Month this April, we are highlighting the Enhance Equity Initiative and our work to raise awareness on the importance of improving the health of racial and ethnic minority populations and reducing health disparities.
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Guidance Documents
Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
This guidance is intended to assist manufacturers on how to label bottled or otherwise packaged beers that are subject to the FDA’s labeling laws and regulations.
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
FDA is issuing this draft guidance to further develop a regulatory approach tailored to artificial intelligence/machine learning (AI/ML)-enabled devices to increase patients’ access to safe and effective AI/ML-enabled devices, in order to protect and promote public health.
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!
Replay! FDA Stakeholder Call - Expanding Access to Naloxone - YouTube
Last week, the FDA approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.
Access to Naloxone Can Save a Life During an Opioid Overdose
Anyone can save a life during an opioid overdose with naloxone, a front-line defense in the nation’s overdose crisis. Naloxone is a life-saving drug that, when sprayed into the nose or injected, quickly reverses the powerful effects of opioids during an overdose.
Everyone who overdoses with opioids, whether with a prescribed medicine or an illicit drug, can use naloxone, including nasal sprays and injections. Examples of opioids include heroin, fentanyl, oxycodone, hydrocodone, codeine, and morphine.
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Webinars and Virtual Workshops
Clinical Trials: The Patient Experience
April 13, 2023; 11:00 AM - 3:00 PM ET
The workshop, Clinical Trials: The Patient Experience, will feature a panel of rare disease patients, caregivers, and advocates who will share their experiences with gene therapy clinical trials. Through participation in clinical trials, patients can help advance the science of gene therapy and further the development of rare disease treatments.
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
April 14, 2023; 9:00 AM - 4:00 PM ET
The committees will discuss supplemental new drug application (sNDA) 205422 s009, efficacy supplement for REXULTI (brexpiprazole) tablets, submitted by Otsuka Pharmaceutical Company, Ltd., and Lundbeck, Inc., for the proposed treatment of agitation associated with Alzheimer’s dementia.
Registration is not required.
Webinar on Guidances on COVID-19 Transition Plans for Medical Devices
April 18, 2023; 1:00 PM - 2:30 PM ET
FDA will host a webinar for stakeholders interested in learning more about the two final guidances on the Coronavirus Disease 2019 (COVID-19) transition plans for medical devices.
During this webinar, the FDA will:
- Help prepare manufacturers and other stakeholders for the orderly and transparent transition to normal operations.
- Describe recommendations regarding submitting a marketing submission and the timeline for doing so.
- Provide examples to illustrate the transition policies and exemplify the 180-day transition period timeline.
- Answer your questions about the guidances on the COVID-19 transition plans.
Registration is not required.
Public Meeting on Patient-Focused Drug Development for Long COVID
April 25, 2023; 10:00 AM - 4:00 PM ET
This meeting will provide FDA the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID, including how Long COVID affects their daily life, symptoms that matter most to patients, their current approaches to treating Long COVID, and what they consider when determining whether or not to participate in a clinical trial.
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.
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