FDA’s Post

Free training, mentoring, and other resources are available for any health care provider who wants to start prescribing or learn more. FDA’s new #PrescribeWithConfidence Campaign has more information: https://lnkd.in/eb_t66cm #MOUDSavesLives #oud #MedEd #recovery

An FDA delegation is traveling to Kenya and Rwanda to demonstrate the FDA's commitment to strengthening regulatory systems in Africa.

During foodborne illness outbreaks the U.S. FDA Coordinated Outbreak Response & Evaluation (CORE) Network works closely with Centers for Disease Control and Prevention and state and local partners to mitigate threats to public health and minimize the impact of future occurrences. In the current issue of Food Safety Magazine, in the article, "Outbreaks of Foodborne Illnesses and Recalls Associated with Ice Cream and Frozen Dessert Products," CORE and CDC share their expertise in #outbreak response to inform prevention. Preventing contamination of ice cream products is a legal requirement for manufacturers, a sound business practice, and most importantly, necessary to protect public health. DYK - People in the U.S. consume an average of 21.2 pounds of frozen dairy products 🍦 annually? Unsurprisingly, production of ice cream peaks in the summer months, with June being the highest. A review of CDC's National Outbreak Reporting System identified five L. monocytogenes outbreaks between 2014 and 2023 linked to ice cream products. https://lnkd.in/e5N9--uW

Did you know that pharmaceutical quality is about more than just the quality of the drug itself? It includes manufacturing facilities and processes used to manufacture the drug. Check out some things to know about CDER’s pharmaceutical quality functions: https://lnkd.in/gtHiiaXK

Today, FDA issued marketing granted orders to NJOY LLC for four menthol-flavored e-cigarette products – NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%. https://lnkd.in/d6qFYCKc While this action permits these specific tobacco products to be legally marketed in the United States, it does not mean these tobacco products are safe nor are they “FDA approved.” All tobacco products are harmful and potentially addictive. Those who do not use tobacco products shouldn’t start. To date, FDA has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices, including the four authorized today. These are the only e-cigarette products that currently may be lawfully marketed and sold in the U.S.

As we close out Healthcare Risk Management Week, we remind you that medical devices that use USB chargers can overheat. Charging cables and accessories supplied by the manufacturer limit the power provided to safely charge the battery, but third-party accessories may allow much higher power, increasing the risk of overheating, spark, or fire, which may lead to minor injuries or serious burns. The FDA encourages you to read, understand, and follow the manufacturer’s instructions. Check out these tips to help you and your patients charge medical devices safely: https://lnkd.in/e4uDtKXU #HRMWeek

Today, FDA expanded the approval of a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene. https://lnkd.in/gBf23-sc

In addition to the new Home as a Health Care Hub web page that launched today, we will be hosting a virtual public meeting in support of the health equity initiative. The meeting will provide information and seek input from stakeholders. Join us on July 25, 2024, from 12:00 noon to 4:00 p.m. ET, for more details on how this initiative will reimagine the home environment as an integral part of the health care system. The deadline to register for the public meeting is 11 a.m. ET on July 25, 2024. If you’d like to speak at the public meeting, please follow the instructions to express your interest before noon on July 12, 2024: https://lnkd.in/gdJEd6ut

Update on our Home as a Health Care Hub initiative. While the Hub is in development, you don’t have to wait to get information about this health equity initiative. For more details on Home as a Health Care Hub’s goals and background, check out the new resource page. Get answers to frequently asked questions and project updates: https://lnkd.in/gmdH5Kdz

FDA issued an update to a draft guidance for industry “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that describes considerations regarding a switching study or studies intended to support a demonstration that a biological product is interchangeable with a reference product: https://lnkd.in/eudfCriB The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science. View the draft guidance: https://lnkd.in/eqZcf8if