News At FDA
FDA Approves New Treatment for Congenital Adrenal Hyperplasia
The FDA approved Crenessity (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).
FDA Issues 2024 Voluntary National Retail Food Regulatory Program Standards
The FDA issued the 2024 edition of the Voluntary National Retail Food Regulatory Program Standards, which defines the key elements of an effective retail food regulatory program for state, local, tribal, and territorial food regulatory agencies.
FDA Voices
Youth Tobacco Product Use Continues to Decline as FDA Actions Build Momentum
By: Dr. Brian King, Director of FDA’s Center for Tobacco Products
The recently released 2024 National Youth Tobacco Survey findings are a monumental win for public health: youth tobacco product use has dropped to its lowest level ever reported since the survey began a quarter century ago. This success is the result of actions taken at the national, state, local, territorial and tribal levels.
FDA In Your Day: FDA’s New Chapter
Recently, the FDA completed one of its largest transformations, impacting almost every part of the agency. This installment of FDA In Your Day highlights two of the many examples of the important work the FDA is doing every day to keep us safe – the newly unified Human Foods Program and the Office of Inspections and Investigations.
Reflections on the 19th International Conference of Drug Regulatory Authorities
By: Kimberlee Trzeciak, FDA Deputy Commissioner for Policy, Legislation, and International Affairs
The Office of Global Policy and Strategy published its latest From a Global Perspective about the importance of the FDA working with foreign regulators to achieve our shared goal of advancing global health.
The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball
Conversation with: Dr. Ellicia Weber and Dr. Robert Ball
This episode of the CDER Small Business and Industry Assistance Chronicles Podcast discusses how AI can be used in drug safety.
Upcoming Events
Webinar on Allergen Labeling for Retail Food Stores and Food Service Establishments
December 18, 2:00 p.m. - 2:45 p.m. ET, Virtual
The U.S. Food and Drug Administration (FDA) will host an educational webinar to provide an overview of food labeling and food allergen labeling requirements and compliance.
Webinar – Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
January 14, 2:00 p.m. - 3:15 p.m. ET, Virtual
The FDA will host a webinar for industry and other interested stakeholders to answer questions about the final guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.
FY25 FDA Broad Agency Announcement Question and Answer Session
January 16, 1:00 p.m. - 2:30 p.m. ET, Virtual
This webinar will provide the opportunity for applicants to learn more about the application process, next steps, and clarify questions about applying for extramural research funding through the FDA Broad Agency Announcement.
In Case You Missed It
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.
Some Medicines and Driving Don’t Mix
Some nonprescription and prescription medications can have side effects that may make it unsafe to drive.
Keep Your Dogs and Cats Safe from Holiday Hazards
Happy holidays? Not so much if your pet gets sick. The Food and Drug Administration’s Center for Veterinary Medicine discusses some unhealthy holiday temptations to avoid and how to keep your pets safe.
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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