News At FDA
FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
The FDA announced a proposed rule to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetic products. This proposed rule, if finalized, will help protect consumers who use talc-containing cosmetic products from harmful exposure to asbestos. This proposal is part of the agency’s work to fulfill the requirements of section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
The FDA approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
FDA Approves First Medication for Obstructive Sleep Apnea
The FDA approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity.
FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
The FDA approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow) is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers
The FDA is announcing a final rule to update the definition of the nutrient content claim “healthy.” The "healthy" claim has been updated to help consumers find foods that are the foundation of a healthy dietary pattern and could also result in the development of healthier foods. The updated “healthy” claim marks an important step in fulfilling the FDA’s nutrition priorities. This rule will help ensure that consumers have access to more complete, accurate, and up-to-date nutrition information on food labels.
FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease
The FDA approved Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients 2 months of age and older.
Justice Department Announces Resolution of Criminal and Civil Investigations into McKinsey & Company’s Work with Purdue Pharma L.P.; Former McKinsey Senior Partner Charged with Obstruction of Justice
McKinsey & Company Inc. (McKinsey), a global management consulting firm based in New York, has agreed to pay $650 million to resolve a criminal and civil investigation into the firm’s consulting work with opioids manufacturer Purdue Pharma L.P. (Purdue).
FDA Voices
Partnership in Action: Creating Safeguards for Imported Products Entering the United States in the Pacific Islands
By: Dan Solis, Assistant Commissioner for Import Operations
The Pacific Rim is a strategically significant location when it comes to ensuring the safety of products bound for consumers in the United States. A little more than a third of global products coming into our country originate in the Asia-Pacific Region, making it an ideal location for us to act as sentinels and gather intelligence regarding imported products, ensuring they will be safe for American consumers.
FDA In Your Day: What is Whooping Cough? How to Protect Yourself and Others
Here's what you should know about whooping cough (pertussis) and how to protect yourself and others.
FDA Office of Criminal Investigations Agents Catch Doctor Who Poisoned Patients with Tainted IV Bags
By: Rachael Burden, Public Affairs Specialist, Office of Inspections & Investigations
This feature story highlights the work conducted by the FDA Office of Criminal Investigations that identified the suspect responsible for tampering with IV bags at Baylor Surgicare in North Dallas, TX.
Upcoming Events
FDA Grand Rounds - The PATH from Data to Action: Key Findings from the Population Assessment of Tobacco and Health (PATH) Study to Inform FDA’s Regulatory Activities
January 9, 12:00 p.m. - 1:00 p.m. ET, Virtual
This virtual presentation will share an overview and history of the Population Assessment of Tobacco and Health (PATH) Study and describe how scientific data generated from the PATH Study supports tobacco regulatory science and public health.
OCE Conversations on Cancer, Cervical Cancer Treatment Innovation: A Collaborative Discussion
January 14, 10:00 a.m. - 11:00 a.m. ET, Virtual
This virtual webcast will bring together key stakeholders in the fight against cervical cancer to discuss the historical path that has led us to the current treatment landscape, the impact of new therapies on individuals with cervical cancer and their families, areas of ongoing high impact research, and what the future might bring.
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.
A Fresh Take on What "Healthy" Means on Food Packages
To help consumers build nutritious diets, the FDA updated the nutritional requirements a food must meet to use the claim "healthy" on the package.
Skip the Antibacterial Soap; Use Plain Soap and Water
There isn’t sufficient evidence to show that OTC antibacterial soaps are better at preventing illness than washing with plain soap and water.
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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