News At FDA
Biden-Harris Administration Announces National Strategy to Reduce Food Loss and Waste and Recycle Organics
The FDA, the U.S. Department of Agriculture (USDA), and the U.S. Environmental Protection Agency (EPA) announced the “National Strategy for Reducing Food Loss and Waste and Recycling Organics” as part of President Biden’s whole-of-government approach to tackle climate change, feed people, address environmental justice, and promote a circular economy.
Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes
The U.S. Department of Justice (DOJ) and the FDA announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes.
10 Things to Know about CDER’s Pharmaceutical Quality Functions
Pharmaceutical quality provides confidence that a patient’s next dose of medicine is safe, effective, and available when it’s needed.
Intelligence Program: Research on AI/ML-Based Medical Devices
The Artificial Intelligence (AI) Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to ensure patient access to safe and effective medical devices using artificial intelligence/machine learning (AI/ML).
Voices in Health Equity
FDA In Your Day: Opioid Use Disorder, New Biosimilar, Black Family Cancer Awareness Week
In this video, Principal Deputy Commissioner Dr. Namandjé Bumpus discusses the FDA’s Prescribe with Confidence campaign, three biosimilar approvals, a public meeting on Engaging the Generations as part of National Black Family Cancer Awareness Week, and the virtual listening session on advisory committee meetings.
Join Us in Recognizing National Black Family Cancer Awareness Week
By: Richard Pazdur, MD, Director, Oncology Center of Excellence (OCE), and Rea Blakey, Associate Director for External Outreach and Engagement, OCE
Join the “4th Annual National Black Family Cancer Awareness Week, Engaging the Generations” initiative and the #BlackFamCan social media campaign this year, June 13-19. The event is virtual and open to the public.
When We Work Together, Hand in Glove with Our Partners, We Can Overcome Any Barrier: A Conversation with EMA's Emer Cooke
By Emer Cooke, EMA Executive Director
This interview is the latest in the FDA’s blog series From a Global Perspective. The interview followed FDA Commissioner Robert Califf‘s trip to the European Medicines Agency in February and April’s FDA-EU Bilateral in Washington.
The Role of Artificial Intelligence in Clinical Trial Design and Research with Dr. ElZarrad
From the Q&A with FDA Podcast
Join Dr. Sara Roach and Dr. Khair ElZarrad for a conversation on recent advances and the use of technology like artificial intelligence in clinical trial design.
Upcoming Events
FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference
June 18-20, 11:00 a.m. – 4:15 p.m. ET all days, Virtual
This three-day virtual conference hosted by the FDA Office of Regulatory Affairs is intended to share information among FDA representatives and the regulated community to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the research professional’s product development experience.
How Are Institutions Transformed to Foster Cultures of Inclusive Excellence?
June 20, 1:00 p.m. - 2:30 p.m. ET, Virtual
The NIH is hosting a virtual seminar that will focus on strategies to enhance inclusion and create a culture of equity within the scientific workforce at academic institutions as well as methods for assessing culture change.
FDA Workshop: 9th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop
June 25, 11:00 a.m. - 2:30 p.m. ET, Virtual
The FDA Oncology Center of Excellence is hosting a workshop to provide a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials.
Mesoamerican Nephropathy: Genes and Environment in a Kidney Disease Hotspot
June 26, 2:00 p.m. - 3:00 p.m. ET, Virtual or In-person
This virtual webinar is part of the Genomics and Health Disparities Lecture Series, which was formed to enhance opportunities for dialogue about how innovations in genomics research and technology can impact health disparities. The lecture series is co-sponsored by institutes at the National Institutes of Health (National Human Genome Research Institute, National Heart, Lung and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute on Minority Health and Health Disparities) and the Office of Minority Health at the Food and Drug Administration.
Co-sponsored Public Workshop - Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Lifecycle
June 26-27 11:00 a.m. - 3:00 p.m. ET both days, Virtual
The FDA and Digital Medicine Society (DiMe) are co-sponsoring a public workshop where patients, industry sponsors, regulators, and researchers will share their perspectives on how using patient-generated health data can help advance remote clinical trial data collection and support clinical outcome assessments.
FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Exploring Religious Literacy and Spirituality in Cancer Care”
July 10, 2:00 p.m. - 3:30 p.m. ET, Virtual
Join the FDA Oncology Center of Excellence for a public panel discussion on the role of religious literacy and spirituality in cancer care.
Online Controlled Substances Summit
July 25, 11 a.m. - 3 p.m. ET, July 26, 11 a.m. – 4:00 p.m. ET; Virtual
The FDA, in partnership with the Reagan-Udall Foundation for the FDA, is hosting a two-day virtual public meeting to identify innovative solutions to reduce the illegal availability of controlled substances online.
Opportunities
Request for Information: FDA-NIH Resource on Terminology for Clinical Research
The FDA and the National Institutes of Health (NIH) published a request for information seeking public comments on a proposed glossary of clinical research terminology. This glossary is intended to facilitate communication within the clinical research community, by helping establish a common vocabulary to more uniformly characterize clinical research.
The deadline for submitting comments is June 24, 2024.
In Case You Missed It
Managing Risk Factors for Heart Disease
During Men’s Health Month, talk to your health care provider about managing heart disease risk factors. Heart disease is the leading cause of death for men in the United States. There are many FDA-approved treatments and medical devices available for heart disease and heart disease risk factors.
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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