Pride Month 2023
 June is Pride Month! During this observance, the FDA Office of Minority Health and Health Equity (FDA OMHHE) will lift up our Equity of Voices video series, which showcases some LGBTQ+ community members and their positive experiences with antiretroviral therapy.
The FDA OMHHE also invites you to look out for our upcoming Health Equity Forum podcast episode, which discusses the FDA’s finalized recommendations for assessing blood donor eligibility. In the meantime, we encourage you to listen to this past podcast episode: “PrEP and PEP for HIV Prevention in Older Adults.”
News At FDA
FDA Conducts Retailer Inspection Blitz, Cracks Down on Illegal Sales of Popular Disposable E-cigarettes
The FDA issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products.
FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information
Patient Medication Information would provide patients with clear, concise, accessible, and useful written information for prescription drugs and certain biological products and would be delivered in a consistent and easy-to-understand format to help patients use their prescription drug and certain biological products safely and effectively.
FDA Announces Additional Steps to Modernize Clinical Trials
The FDA announced the availability of a draft guidance with updated recommendations for good clinical practices aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections.
How FDA’s New Approach to Reviewing Chemicals Added to Food Will Strengthen Food Safety
By Robert M. Califf, M.D., Commissioner of Food and Drugs and Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition
In light of this need to continue to assess the safety of food ingredients and food contact substances as new information becomes available, the FDA is embarking on a more modernized, systematic reassessment of chemicals with a focus on post-market review.
FDA Roundup, June 6, 2023
Read the FDA at-a-glance summary of news from around the agency!
Opportunities
Postdoctoral Fellowship in Genomic Science and Health Equity, Summer 2023
The National Institutes of Health’s (NIH) National Human Genome Research Institute (NHGRI) and the Food and Drug Administration’s (FDA) Office of Minority Health and Health Equity (OMHHE) are cosponsoring a fellowship. Applications are being accepted and will be screened on a rolling basis.
CDRH Seeks Public Comment
Public Comment period will end on August 30, 2023
The FDA’s Center for Devices and Radiological Health (CDRH) is seeking input from the public on facilitating access to medical devices designed to be safe and effective when used outside of traditional clinical settings, such as in the home.
Upcoming Events
The FDA Science Forum
June 13, 9:00 a.m.-3:30 p.m. ET and June 14, 9:00 a.m.-2:00 p.m. ET, Virtual
The Forum offers an exciting opportunity for the public to view the unique scientific research and collaborative efforts of FDA’s 11,000 scientists.
Overview: Clinical Pharmacology Considerations for Food Effect Studies
June 15, 1:00-2:00 p.m. ET, Virtual
In this webinar, the FDA will discuss the importance of assessing the effect of food on drugs and reasons for issuing the final guidance; timing of conducting food effect studies during drug development; general considerations for designing food effect studies; and other considerations related to assessing the effect of food on a drug.
OCE Conversation on Cancer: National Black Family Cancer Awareness Week—Engaging the Generations public panel discussion
June 15, 2023: 1:00-2:30 p.m. ET
The FDA Oncology Center of Excellence began its National Black Family Cancer Awareness initiative in 2021 coinciding with the 50th anniversary of the National Cancer Act and the signing of Presidential Executive Order 13985, with a week-long social media campaign to increase cancer awareness in one of the most vulnerable segments of the US population. This initiative, now a year-round project, aims to marshal community-based stakeholders to build knowledge surrounding cancer clinical trial participation and minority population specimen donations to national genomic databases for cancer research. Our 2023 activities began in January with stakeholder meetings and culminate in the one-week social media campaign, June 15-21, starting with this public panel discussion.
Decentralized Clinical Trials (DCT) Draft Guidance
June 20, 3:00-4:00 p.m. ET, Virtual
The FDA is hosting a webinar that will provide an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices.
In Case You Missed It
AANHPI Month
In May, for Asian American, Native Hawaiian, and Pacific Islander (AANHPI) Heritage Month, the FDA OMHHE hosted a Health Equity Lecture Series webinar featuring a conversation with Dr. Frankie Wong, Professor of Health Equity Research at Florida State University.
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.
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