health and wellness
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
5 strategies to combat stressful triggers
(Family Features) Stress, the physical or mental response to external causes like overwhelming work assignments or difficult life moments, can add unnecessary pressure to your day to day. While everyone feels stress from time to time, when left untreated or unrecognized, it can begin to wreak havoc in the form of anxiety.
In honor of National Stress Awareness Month, consider these strategies to combat stress from the National Institutes of Mental Health.
Learn Your Triggers
Different events and situations cause stress for different people. Knowing what triggers your stress to kick in – mounds of office paperwork, important financial decisions or hectic mornings, for example – can help you plan and prepare for stress-inducing moments.
Exercise and Eat Right
Maintaining physical health can be beneficial for mental health, too. Find time to do exercises you enjoy like walking, jogging, yoga or playing a sport. Identifying activities that bring you joy can make it easier to fit 30-60-minute workouts into your schedule without adding even more stress. Complement your workout routine with nutritional meals that help you stay on track with your fitness goals.
Practice Relaxation
Whether you find inner peace through journaling, breathing exercises, reading or some other form of slowing down, find what works for you and prioritize fitting it into your daily schedule. Relaxing activities help you slow down the pace of life, providing a chance to reset by doing something you enjoy.
Get Enough Sleep
A lack of quality sleep can add to stress. Creating a bedtime routine can increase your sleep habits and help you achieve the expert-recommended 7-9 hours per night. Put away electronics, which can interfere with your ability to calm your mind, and find an activity that puts you at ease like reading a book or listening to relaxing music. Ensure your bedroom is optimized for comfort by making it cool, dark and quiet.
Create a Network of Support
Everyone experiences stress. Reach out to family members and close friends you can lean on in stressful and frustrating moments. Share your feelings and encourage others to do the same, which can increase trust and help everyone in your circle cope in a positive way.
Find more ways to combat stress and care for your mental health at eLivingtoday.com.
Photo courtesy of Unsplash
SOURCE:
eLivingtoday.com
(Family Features) For those with asthma, understanding what can trigger symptoms is a part of getting the condition under control. Some of the same things that cause allergies can worsen symptoms, but not every allergen is a trigger for everyone with asthma. The places where you live, learn, work and play can expose you to common asthma triggers like pet dander, dust mites, pests like rodents and cockroaches, mold, cigarette smoke, pollen, air pollution and more. Managing triggers is just one part of controlling asthma, however. Work with your health care provider to make an asthma action plan and keep track of your symptoms and where you are when they occur. Learn more at nhlbi.nih.gov/BreatheBetter.
Food and Beverage
The 10 Best Healthiest Seafood Options: Nutrient-Rich and Sustainable Choices
“From sardines to salmon, discover the top 10 healthiest and sustainable seafood options for a nutrient-rich diet. 🐟🌱 #Seafood”
Seafood is a treasure trove of essential nutrients and beneficial compounds that can significantly contribute to a healthy diet. From the omega-3 fatty acids that promote heart health to the abundance of vitamins and minerals, incorporating seafood into your meals can have a positive impact on your overall well-being. In this blog post, we will delve into the ten best healthiest seafood options, considering their nutritional content, sustainability, and potential contaminants.
- Sardines:
These small fish are incredibly nutritious, packed with omega-3 fatty acids, vitamin B12, vitamin D, and calcium. Sardines are also low in contaminants and are considered one of the most sustainable seafood options available. - Salmon:
Salmon is well-known for its impressive omega-3 content. It also provides high-quality protein, vitamin D, vitamin B12, and selenium. Opt for wild-caught Alaskan salmon for the best nutritional benefits and sustainability. - Oysters:
Oysters are a true nutritional powerhouse, rich in vitamins B12, D, and zinc. They are a sustainable choice and an excellent source of lean protein. Including oysters in your diet not only benefits your health but also supports local marine ecosystems due to their ability to filter water. - Mackerel:
Mackerel is another fish that boasts high levels of omega-3 fatty acids, along with vitamin D, vitamin B12, and selenium. This flavorful fish is considered a sustainable choice and offers numerous health benefits. - Rainbow Trout:
Rainbow trout is a deliciously mild-flavored fish that is packed with omega-3 fatty acids, protein, vitamin B12, and iron. It is a sustainable choice, particularly when sourced from responsible fish farms. - Clams:
Clams are an excellent source of protein, vitamin B12, iron, and selenium. They are sustainable, low in contaminants, and make a versatile addition to dishes like pasta, chowders, and stir-fries. - Herring:
Herring is an oily fish that delivers a healthy dose of omega-3 fatty acids, vitamin D, and vitamin B12. It is an eco-friendly choice and can be enjoyed smoked, pickled, or grilled. - Cod:
Cod is a lean white fish that provides protein, vitamin B12, selenium, and phosphorus. It is known for its mild flavor and versatility in cooking methods. - Shrimp:
Shrimp is low in calories and rich in protein, vitamin D, and selenium. Choose sustainably sourced shrimp to minimize environmental impact and ensure a healthier choice. - Anchovies:
Anchovies may be small in size, but they are big in nutritional value. These tiny fish deliver omega-3 fatty acids, calcium, and vitamins D and E. They are also a sustainable choice when sourced responsibly.
When it comes to the healthiest seafood options, there is an abundance of choices that offer an array of essential nutrients while also being environmentally responsible. Sardines, salmon, oysters, mackerel, rainbow trout, clams, herring, cod, shrimp, and anchovies are all fantastic choices to boost your overall health while supporting sustainable fishing practices. Incorporate these nutrient powerhouses into your diet and savor the benefits they provide for your well-being and the planet.
What are the Risks of Eating Seafood?
Although seafood is a nutritious option to fulfill dietary nutrient gaps, there are some environmental and health concerns related to its consumption.
Seafood may contain toxins, viruses, parasites, and bacteria that can be harmful if consumed. To avoid getting sick, it is essential to cook fish and shellfish thoroughly. As per the USDA guidelines, most seafood should be cooked to an internal temperature of 145 degrees Fahrenheit.
Contaminants, including Mercury and Others
Overconsumption of certain seafood varieties can have negative health effects due to the presence of contaminants. For instance, specific fish species contain high levels of mercury, a heavy metal that can be easily absorbed by the body. Mercury accumulation is more common in larger fish, as they consume smaller fish that have ingested mercury-rich plankton. Consequently, larger and older fish are typically the most mercury-contaminated.
Regularly consuming foods high in mercury can result in mercury accumulation in the body, leading to health problems like high blood pressure, heart attack, and developmental delay in offspring. Mercury is toxic and can have detrimental effects on the body.
Mercury can have a greater impact on certain groups, such as pregnant and breastfeeding women, as well as children, who are more susceptible to its effects.
To reduce the amount of mercury in your diet, avoid consuming seafood like shark, certain types of tuna, swordfish, tilefish, and king mackerel as they have high mercury levels. Instead, opt for low-mercury options such as trout, cod, oysters, clams, herring, salmon, and sardines.
Recommendations for Incorporating Seafood into Your Eating Plan
Eating seafood can boost the quality of your diet and support and protect your health. However, it’s important to consider the nutrition and environmental impact of seafood when narrowing down options to add to your diet.
Adding seafood to your diet can boost its nutritional quality and promote your overall health. However, it is essential to consider the nutritional composition and environmental impact of various seafood options before including them in your meals.
Read the article in Health titled Healthiest Seafood Options, Ranked for further insight into the topic. https://www.health.com/healthiest-seafood-8630471
https://stmdailynews.com/category/food-and-beverage/
-
Community1 year agoDiana Gregory Talks to us about Diana Gregory’s Outreach Services
-
Senior Pickleball Report1 year ago
ACE PICKLEBALL CLUB TO DEBUT THEIR HIGHLY ANTICIPATED INDOOR PICKLEBALL FRANCHISES IN THE US, IN EARLY 2023
-
Entertainment1 year ago
The Absolute Most Comfortable Pickleball Shoe I’ve Ever Worn!
-
Automotive1 year ago
2023 Nissan Sentra pricing starts at $19,950
-
Blog1 year ago
Unique Experiences at the CitizenM
-
Senior Pickleball Report1 year ago
“THE PEOPLE’S CHOICE AWARDS OF PICKLEBALL” – VOTING OPEN
-
Blog1 year ago
Assistory Showing Support on Senior Assist Day
-
influencers1 year ago
Keeping Pickleball WEIRD, INEXPENSIVE and FUN? These GUYS are!
