 REACHing Communities Video Series - Myra Parker
The FDA Office of Minority Health and Health Equity (OMHHE) launched a new REACHing Communities video series, which features interviews with members of the OMHHE Racial and Ethnic Minority Acceleration Consortium for Health Equity, also known as REACH. Hear from Dr. Myra Parker on her ongoing work exploring perceptions of clinical trials among American Indian and Alaska Native communities in the Northern Plains.
News At FDA
FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency
The FDA approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency.
FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review
The FDA announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion after an agency review of the available data determined that oral phenylephrine is not effective for this use.
Voices in Health Equity
One Health - Optimal Public Health Outcomes for Humans and Animals in Our Shared Environment
By: Robert M. Califf, MD, Commissioner of Food and Drugs
The FDA collaborates with stakeholders across disciplines and sectors to promote the health of humans, animals, and the environment using science, technology, and innovation.
FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub
By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
The Rare Disease Innovation Hub (the Hub) is an FDA cross-center program that will act as the single point of engagement and connection with outside parties for drug and biological product development and as a forum for the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) to collaborate on cross-cutting rare disease-related issues. Through the Hub, we plan to foster a community at the FDA for open dialogue and knowledge sharing to identify new approaches to drug and biologic development and overcome hurdles that have traditionally impeded progress for rare disease treatments.
FDA In Your Day: Food Safety Tips for the Holidays
Chief Medical Officer, Dr. Hilary Marston reviews some basic tips that can help keep everyone safe this holiday season.
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.
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.
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.
In Case You Missed It
Food Safety Tips for Healthy Holidays
Following safe food-handling practices will help prevent food poisoning, also called foodborne illness.
It's a Good Time to Get Your Flu Vaccine
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 (influenza).
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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