FDA CDC News
Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing
Today, the U.S. Food and Drug Administration is announcing steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment to addressing the ongoing outbreak.
“Since the beginning of the monkeypox outbreak, the agency has used the full breadth of its authorities to work quickly and proactively to ensure the availability of medical countermeasures, including diagnostics, to prevent the spread of the disease,” said FDA Commissioner Robert M. Califf, M.D. “We will continue to engage federal public health partners like the Centers for Disease Control and Prevention, laboratories, commercial manufacturers, health care professionals, and consumers to facilitate the availability of monkeypox tests to people and communities who need them.”
Since the first case of monkeypox was detected in the U.S., the FDA has been:
- working with the CDC to increase production and distribution of the FDA-cleared CDC non-variola orthopoxvirus test;
- clearing the use of additional reagents and automation to increase the testing capacity of laboratories using the CDC test;
- proactively engaging with commercial manufacturers on the development and validation of both lab-based molecular diagnostic tests and rapid molecular or antigen tests for use at the point-of-care (such as clinics) or at home;
- facilitating the development and availability of test components to help high-complexity CLIA-certified laboratories develop tests for monkeypox; and
- monitoring tests that have been developed and used since the start of the outbreak. For example, on July 15, the FDA issued a safety communication recommending the use of lesion swabs to avoid false results.
New Guidance to Facilitate Development of Additional Tests
Today, the FDA issued guidance that outlines the agency’s current thinking regarding enforcement policies, recommendations for emergency use authorization (EUA) requests for monkeypox diagnostic tests, and the FDA’s plans to prioritize review of EUA requests. The agency is also providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. These templates include recommendations – not requirements – for how a developer could validate a test to help ensure it is appropriately accurate and reliable. The FDA intends to update its recommendations, as needed, in response to the developing emergency.
This guidance follows a declaration by the Secretary of the Department of Health and Human Services justifying the emergency use of in vitro diagnostics for detection and/or diagnosis of the monkeypox virus or non-variola orthopoxviruses. Under the declaration, the FDA may issue an EUA to allow the use of unapproved in vitro diagnostics or unapproved uses of approved in vitro diagnostics.
“Today’s important actions further aid the monkeypox response by working toward expanding vital testing capacity and facilitating the detection of cases nationwide in an effort to stem the spread of the virus,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The policy announced today is intended to support the development of more validated monkeypox tests and expand access to testing.”
As explained in the guidance, the FDA does not intend to enforce requirements for certain tests developed by laboratories that are used without submission of an EUA request where they are appropriately validated and the laboratories notify the FDA within 30 days, among other things. The agency’s intent is to facilitate the development of additional tests to address local availability and accessibility concerns not addressed by current testing capabilities. The FDA will monitor the situation and may adjust its policies as appropriate to address testing needs. The FDA also may decide, on a case-by-case basis, not to object to individual labs offering tests using different specimen types or technologies to address patient care needs.
Commercial manufacturers who intend to make a diagnostic test for monkeypox and want to seek authorization through the more streamlined EUA process should inform the FDA of their plans within 30 days, as well.
It is important that all tests be appropriately validated prior to use, as false results can have a negative impact on both the individual patient and the public health broadly. Currently, only lesion swabs have been shown to be an appropriate specimen type for diagnosing monkeypox. If and when other specimen types are validated, the FDA will inform the developer community and the public. Test developers are encouraged to discuss alternative specimen types, technologies, and approaches to validating their test with the agency.
FDA Authorizes Quest Diagnostics Monkeypox Virus Real-Time PCR Test
In addition to the FDA’s guidance, the agency issued the first EUA for a monkeypox in vitro diagnostic. The Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR is intended to detect monkeypox and other non-variola orthopoxvirus DNA using lesion swab specimens. Quest Diagnostics submitted data demonstrating that its test for distribution to other laboratories met the standards for issuance of an EUA.
Related Information
Source: FDA
https://stmdailynews.com/category/lifestyle
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FDA CDC News
Popular Nasal Decongestant Falls Short: FDA Advisers Question Efficacy
FDA questions effectiveness of popular nasal decongestant phenylephrine, raising concerns about congestion relief.
In a surprising turn of events, government experts have cast doubt on the effectiveness of the leading decongestant found in popular over-the-counter medications like Sudafed and Dayquil. A recent review conducted by the Food and Drug Administration (FDA) found that the main drug ingredient, phenylephrine, offers no significant relief from nasal congestion. This revelation raises concerns among millions of Americans who rely on these medications for congestion relief.
Phenylephrine became the primary ingredient in over-the-counter decongestants after pseudoephedrine, an older ingredient, was moved behind pharmacy counters due to its potential for illegal drug processing. However, the FDA’s outside advisers unanimously voted against the efficacy of phenylephrine, prompting a reevaluation of its effectiveness. Despite phenylephrine-based versions dominating the market, accounting for four-fifths of the $2.2 billion oral decongestant market, the FDA’s conclusions suggest a need to reconsider their availability.
The FDA review identified significant flaws in the original studies that supported phenylephrine’s approval. These studies, conducted in the 1960s and 1970s, were deemed inadequate by modern standards. Furthermore, three recent, well-conducted studies by reputable pharmaceutical companies found no discernible difference between phenylephrine medications and placebos in relieving congestion. This raises concerns about the effectiveness of phenylephrine, which has relied on outdated research.
The FDA’s advisory panel’s unanimous vote against phenylephrine’s effectiveness could lead to regulatory action requiring drugmakers like Johnson & Johnson and Bayer to withdraw their phenylephrine-based oral decongestants from store shelves. This move may force consumers to opt for behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops. However, it would necessitate extensive education efforts by the FDA, pharmacists, and drugstores to inform consumers about alternative options for treating congestion.
The Consumer Healthcare Products Association, representing nonprescription drugmakers, argued that the recent studies have limitations and advocated for continued “easy access” to phenylephrine. However, the FDA review highlighted the shortcomings of the original studies and the lack of modern scientific evidence supporting phenylephrine’s efficacy. Balancing public health concerns and consumer access will be a crucial challenge for regulators moving forward.
The FDA’s recent review has cast doubt on the effectiveness of phenylephrine, the key ingredient in popular nasal decongestants. This finding prompts a reevaluation of treatment options for nasal congestion and calls for further research to provide effective relief for individuals in need.
Check out the article from the Associated Press: https://apnews.com/article/sudafed-decongestants-phenylephrine-pseudoephedrine-fda-0f140bafae9a500c5fba05fe764ecb66
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
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FDA CDC News
Important Recall Alert – Listeria Contamination in Meal Kits
In recent news, Reser’s Fine Foods has issued a recall on several of its popular meal kits due to potential contamination with Listeria monocytogenes, a harmful bacteria known to cause food poisoning. This recall was prompted by the inclusion of chicken from their ingredient supplier, BrucePac, which has also been recalled due to contamination concerns.
What Products Are Affected?
The affected meal kits include a variety of delicious options that many consumers may have purchased. These products consist of:
- Taco Meal Kits
- Enchilada Meal Kits
- Quesadilla Meal Kits
- Stir Fry Meal Kits
- Salad Meal Kits
All of these products have been classified under a Class II recall by the U.S. Food and Drug Administration (FDA), indicating that while exposure may lead to temporary or medically reversible health consequences, the probability of serious adverse health effects is remote.
Understanding Listeria
Listeria monocytogenes is a bacterium that can lead to listeriosis, a serious infection typically caused by eating contaminated food. Symptoms can include fever, muscle aches, and gastrointestinal issues. Pregnant women, newborns, older adults, and individuals with weakened immune systems are particularly vulnerable to severe outcomes from listeriosis.
What Should Consumers Do?
If you have purchased any of the affected meal kits, it is crucial to check the packaging for any recall notices. Consumers should discard any recalled products or return them to the place of purchase for a refund. It is also advisable to stay informed by checking official announcements from the FDA and Reser’s Fine Foods regarding the recall.
Stay Informed
For the latest updates and more detailed information about this recall, visit the following resources:
Stay vigilant and prioritize your health by being aware of food recalls and potential safety issues. Your safety is paramount, so always make sure to stay informed about the food products you consume.
Related link:
https://www.newsweek.com/taco-meal-kit-recall-30-states-fda-1978552
At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.
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Daily News
Is There an E. Coli Outbreak at McDonald’s? What You Need to Know
McDonald’s faces an E. coli outbreak linked to Quarter Pounders, with 75 cases reported. The company is investigating potential onion contamination and prioritizing customer safety.
In the fast-paced world of fast food, health and safety are paramount. Recently, McDonald’s has been at the center of an alarming E. coli outbreak linked to their popular Quarter Pounders. With at least 75 reported cases across 13 states, including serious hospitalization and even a death, many consumers are understandably concerned. Let’s break down the situation, what officials are saying, and how McDonald’s is responding to the crisis.
The Details of the Outbreak
Reports have confirmed that this E. coli outbreak is associated with Quarter Pounders sold across various McDonald’s locations. As of now, Colorado and Montana have recorded the highest number of illnesses, causing health officials to raise the alarm. The symptoms of E. coli infection can be severe and include stomach cramps, diarrhea, and vomiting, which can lead to life-threatening complications, especially in vulnerable populations.
Possible Cause: Onions?
Amidst this distressing news, McDonald’s has identified a potential link to onions used in their Quarter Pounder recipe. While investigations are ongoing, the company is taking proactive measures by gradually reintroducing the Quarter Pounder to their menu without the traditional onions. This decision reflects their commitment to ensuring customer safety while addressing supply issues that may have arisen from the outbreak.
McDonald’s Response
In light of the ongoing investigation, McDonald’s has expressed its dedication to maintaining high food safety standards. They have collaborated closely with health officials, including the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), to trace the source of the contamination and prevent further incidents.
As they navigate this situation, the fast-food giant is emphasizing transparency with their customers. They have urged people to stay informed through official communication channels and monitor updates about the progress of the outbreak and safety measures being undertaken.
Consumer Safety: What Can You Do?
As the situation unfolds, it is essential for consumers to remain vigilant about their food choices:
- Stay Updated: Follow news reports and health advisories to keep track of the latest developments regarding this outbreak and any additional safety alerts.
- Practice Good Hygiene: Always wash your hands before eating, and keep an eye on cleanliness when dining out.
- Consider Menu Options: If you’re concerned about the outbreak, consider ordering items that do not contain ingredients linked to health risks or opt for menu items that have been specifically noted as safe.
- Know the Symptoms: Familiarize yourself with the signs of E. coli infection, and if you or someone you know experiences severe symptoms following a visit to McDonald’s, seek medical attention immediately.
The recent E. coli outbreak tied to McDonald’s Quarter Pounders has undoubtedly raised concerns among consumers, but the company is actively working to address the situation and safeguard the health of its patrons. While it’s human nature to worry about food safety, especially with such a concerning issue at hand, it’s also important to empower ourselves with knowledge and the right precautions.
As McDonald’s rolls out their menu changes, we hope that they can swiftly resolve this situation, ensuring that everyone can enjoy their meals with renewed confidence. Let’s all take a moment to prioritize food safety in our daily dining habits, and keep the conversation going around this crucial topic. Always stay informed, stay safe, and enjoy your meals wisely!
Read the release from McDonald’s corporate news site https://corporate.mcdonalds.com/corpmcd/our-stories/article/always-putting-food-safety-first.html
At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.
Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.
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