 ICYMI: National Native American Heritage Month Webinar
In honor of National Native American Heritage Month in November, the FDA Office of Minority Health and Health Equity (OMHHE) hosted the latest installment of the Health Equity Lecture Series titled, “National Native American Heritage Month: A Conversation with Dr. Casey Dorr.”
For this webinar, OMHHE Director, Dr. Cheryl Anne Boyce, interviewed Dr. Casey Dorr, an Investigator in the Nephrology Department at Hennepin Healthcare Research Institute in Minneapolis. Dr. Dorr, a first generation descendent of the Mille Lacs Band of Ojibwe, discussed his research in pharmacogenomics and his ongoing work to improve representation among researchers, including Native American researchers and other underrepresented populations.
News At FDA
USDA-FDA Seek Information About Food Date Labeling, Aim is to Provide Further Clarity, Transparency and Cost Savings for U.S. Consumers
The FDA and the U.S. Department of Agriculture (USDA) announced a joint Request for Information (RFI) about food date labeling, which includes the use of terms such as ‘Sell By,’ ‘Use By’ and ‘Best By’. The RFI seeks information on industry practices and preferences for date labeling, research results on consumer perceptions of date labeling and any impact date labeling may have on food waste and grocery costs.
Commenters will have 60 days to provide comments responsive to one or more of the 13 questions posed. Further information on how to submit a comment can be found here.
FDA Drug Topics Webinars
FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors educational webinars targeting the needs of health care professionals. These focused webinars support FDA's mission of promoting and protecting public health through interaction and education to strengthen current and future partnerships and relationships with clinicians and researchers.
Outbreak Investigation of E. coli O121:H19: Organic Carrots
The FDA issued an advisory for an outbreak of E. coli O121:H19 infections linked to organic whole and baby carrots supplied by Grimmway Farms of Bakersfield, California. Read more about the voluntary recall initiated by Grimmway Farms and about the symptoms of E. coli.
Voices in Health Equity
Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice
By: Justin D. Green, MBA, MDiv., Assistant Commissioner, FDA Office of Criminal Investigations
For more than 30 years, OCI investigators have been conducting and coordinating criminal investigations of suspected illegal activities involving FDA-regulated products, arresting bad actors, and referring cases to the Department of Justice for prosecution.
From Our Perspective: OMUFA – Past, Current, and Future
By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Theresa Michele, M.D., Director, CDER Office of New Drugs’ Office of Nonprescription Drugs
Over-the-Counter (OTC) drugs have long provided an efficient, low-cost way for Americans to take care of everyday health needs, without having to visit a doctor and obtain a prescription.
FDA In Your Day: Flour is a Raw Food!
You may not realize it, but most flour is a raw food! This installment of FDA In Your Day presents some helpful online resources for safely handling flour and eggs.
FDA In Your Day: More Information on Recalls
Ever hear about a food or drug being recalled and wonder “Where can I get more information?” Check out this episode of FDA In Your Day to learn how you can find more information on recalls.
Preparing for the Next Pandemic: Lessons Learned and the Path Forward
Testimony by: Hilary Marston, M.D., M.P.H., Chief Medical Officer, Food and Drug Administration
The COVID-19 pandemic, the response to Highly Pathogenic Avian Influenza (HPAI) in dairy cattle, as well as emergency-induced supply chain disruptions causing shortages of medical products have underscored the need to continue to optimize our nation’s preparedness and response capabilities.
Upcoming Events
FDA CBER Patient Listening Meeting: Patient and Care Partner Perspectives on Early Enrollment into Gene Therapy Clinical Trials for Rare Disease
December 4, 11:00 a.m. to 4:30 p.m. ET, Virtual
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 enrollment of rare disease patients into gene therapy clinical trials in the pre-symptomatic or early symptomatic stages of their disease.
Clinicians Connect: Conversations with FDA’s Chief Medical Officer on reducing the cases of congenital syphilis and syphilis
December 4, 1:00 p.m. - 2:00 p.m. ET, Virtual
In this virtual webcast, clinicians will hear directly from the FDA, CDC, HHS, and NIH about what we can do to address the recent surge in syphilis and its impact on individuals, pregnant people and babies.
Clinical Pharmacology Considerations for Novel Therapeutic Modalities
December 4, 1:00 p.m. - 3:00 p.m. ET, Virtual
During this webinar, FDA subject matter experts will discuss the clinical pharmacology considerations for the development of novel therapeutic modalities. To support the growing number of novel therapeutics, the final guidances on oligonucleotide therapeutics and antibody-drug conjugates will be highlighted and described in detail. The presenters will communicate when the recommendations described in the guidances should be considered and what types of assessments are suitable to address the topics listed above during drug development.
NIH 2026-2030 Minority Health and Health Disparities Strategic Plan
December 4, 1:00 p.m. – 3:00 p.m. ET, Virtual
The National Institutes of Health (NIH) is seeking input through this virtual townhall to identify the most pressing concerns in minority health and health disparities for the next five years. Share your experiences, insights and ideas to help shape the future of minority health and health disparities research efforts.
Navigating the Transition to Low Global Warming Potential Propellants
December 4 - 5, 8:30 a.m. – 5:30 p.m. ET both days, Virtual and In-person
The purpose of this two-day workshop is to engage subject matter experts from academia, brand name and generic drug industries, and health and regulatory agencies to discuss the current scientific understanding of LGWP propellants and the challenges encountered by the drug industry as they advance their transition development programs.
FDA Clinical Investigator Training Course (CITC) 2024
December 10, 11:00 a.m. - 3:30 p.m. ET; December 11, 11:00 a.m. - 4:00 p.m. ET; December 12, 11:00 a.m. - 3:05 p.m. ET; Virtual
The primary goal of this virtual training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.
FDA Grand Rounds - Genomic Perspectives on Foodborne Illness
December 12, 12:00 p.m. - 1:00 p.m. ET, Virtual
This virtual webcast explores the age distribution of foodborne illnesses and explains the evidence supporting the inference that the many small, independent contamination episodes are due to distribution from central sites as opposed to local sources.
Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products
December 12, 12:30 p.m. - 5:00 p.m. ET, Virtual and In-person
The FDA is announcing a free public workshop that will focus on recent accomplishments, ongoing opportunities & challenges, and forward-looking initiatives regarding FDA’s Real-World Evidence Program for drugs and biological products.
Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data
December 13, 10:00 a.m. - 5:00 p.m. ET, Virtual
This virtual public workshop will discuss methodological challenges related to patient experience data, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders.
Opportunities
New Federal Advisory Committee Now Accepting Nominations for Membership
CMS announced the establishment of a new federal advisory committee, the Health Equity Advisory Committee (HEAC), and is seeking nominations for members to serve on it. The HEAC will be composed of 20-30 members that will serve at least 2 years. During that time, committee members will provide information, advice and recommendations to CMS on matters related to equitable access to all CMS programs.
Nominations are due December 12, 2024.
In Case You Missed It
Know Your Treatment Options for COVID-19
The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use. More therapies are being tested in clinical trials.
Know When and How to Use Antibiotics, and When to Skip Them
Antibiotics save lives but aren’t the answer for every illness. Use antibiotics safely to get well and combat antimicrobial resistance.
Resources For You
OMHHE offers many easy-to-use and culturally-appropriate resources on minority health, health disparities, and related topics. These resources are available to view online, print, or share. Some are available in Spanish and additional languages.
Visit www.fda.gov/HealthEquityResources for more information.
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