FDA CDC News

Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing

Published

2 years ago

September 8, 2022

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.”

Medical staff collect samples from a patient. monkeypox — Medical staff collect samples from a patient by Sergeant Matt Hecht is licensed under CC-CC0 1.0

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

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Lifestyle

Mac and Cheese Recall: Potential Spoilage Concerns Affect Products at Major Retailers

Published

21 hours ago

September 14, 2024

Rod Washington

Mac and Cheese Recall

In a recent announcement by the Food and Drug Administration (FDA), two types of macaroni and cheese products sold at major retailers have been recalled due to concerns over potential spoilage. The recall affects Reser’s American Classics Macaroni & Cheese and Reser’s American Classics Macaroni & Cheese White Cheddar, as part of a broader recall of Reser’s Fine Foods deli salads and refrigerated items.

Scope of the Recall

The affected macaroni and cheese varieties were distributed across five states: California, Illinois, Minnesota, North Dakota, and South Dakota. The specific “use by” dates for the recalled products are as follows:

Reser’s American Classics Macaroni & Cheese: Use by dates of September 14 and September 16, 2024.
Reser’s American Classics Macaroni & Cheese White Cheddar: Use by date of September 11, 2024.

In addition to the macaroni and cheese products, the recall includes a variety of other items such as potato salad, scalloped potatoes, pasta salad, corn, egg salad, spinach dip, gravy, and various desserts.

Cause of the Recall

According to the FDA, the potential spoilage was linked to “temperature abuse” during transportation, specifically due to a malfunctioning refrigeration unit on a trailer. A representative from Reser’s Fine Foods confirmed to FOX Business that the issue was isolated to a single truckload of product delivered to only one distributor location.

“The recall was initiated on July 29, 2024, and no affected products ever made it to the store shelves,” the representative stated. They further reassured consumers that any items purchased from stores are safe to consume.

Retailer Responses

Major retailers, including Safeway, Stop & Shop, and Walmart, which stock Reser’s macaroni and cheese products, have stated that their stores were not impacted by the recall. However, Target, another retailer selling the products, did not provide a comment when contacted by FOX Business.

Consumer Safety First

The FDA and Reser’s Fine Foods have stressed the importance of consumer safety in this situation. While the affected products have not reached store shelves, customers who may have purchased any items from the recalled batch are encouraged to check the packaging for the specified “use by” dates.

As always, consumers are advised to be vigilant about food safety and to report any concerns to their local health department or the FDA. For those who may have questions or require further information regarding this recall, contacting Reser’s Fine Foods directly or checking the FDA’s website can provide additional clarity.

In conclusion, while the recent recall raises concerns over food safety, companies and regulatory agencies are working diligently to ensure that consumers remain informed and protected. As the situation develops, staying updated through reliable sources is essential for maintaining food safety standards in your household.

Read the story on Fox Business.com: https://www.foxbusiness.com/lifestyle/mac-cheese-sold-major-retailers-recalled-potential-spoiling

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FDA CDC News

Important Recall Alert: Milo’s Poultry Farms and Tony’s Fresh Market Eggs Potentially Contaminated with Salmonella

Milo’s Poultry Farms, LLC has recalled eggs under the “Milo’s Poultry Farms” and “Tony’s Fresh Market” labels in Wisconsin, Illinois, and Michigan due to Salmonella contamination, advising consumers to discard or return products.

Published

5 days ago

September 10, 2024

Hal Machina, Daily News Staff

selective focus photo of three eggs on tray — Photo by Monserrat Soldú on Pexels.com

As of September 6, 2024, Milo’s Poultry Farms, LLC, headquartered in Bonduel, Wisconsin, has issued a voluntary recall of all its egg products due to possible contamination with Salmonella. This recall applies to both “Milo’s Poultry Farms” and “Tony’s Fresh Market” branded eggs, spanning across various retail stores and foodservice distributors in Wisconsin, Illinois, and Michigan.

What You Need to Know

Salmonella is a bacteria that can cause serious and occasionally fatal infections, particularly in young children, the elderly, and individuals with weakened immune systems. Healthy individuals infected with Salmonella often experience fever, diarrhea (potentially bloody), nausea, vomiting, and abdominal pain. In severe cases, the infection can result in the bacteria entering the bloodstream and causing more critical conditions such as infected aneurysms, endocarditis, and arthritis.

Scope of the Recall

The recall encompasses:

All carton sizes and types of eggs under the “Milo’s Poultry Farms” label, across all expiration dates.
All carton sizes of “Tony’s Fresh Market” branded eggs, applicable to all expiration dates.
All cases of eggs intended for retail foodservice distribution, regardless of expiration dates.

Reason for the Recall

The recall was triggered after environmental samples collected by the FDA tested positive for Salmonella. Further investigations through whole genome sequencing linked these samples to an ongoing outbreak of Salmonella, prompting immediate action by Milo’s Poultry Farms.

Consumer Safety Measures

Milo’s Poultry Farms, LLC has temporarily halted production and distribution of the affected products to conduct necessary testing and sanitization processes at their facilities.

What Should Consumers Do?

Customers who have purchased any of the recalled eggs are strongly advised not to consume them. These products should be discarded immediately or returned to the place of purchase for a full refund.

Consumers with additional questions or concerns can reach out directly to Milo’s Poultry Farms, LLC at (715) 758-6709 for further guidance and support.

Stay Informed

Salmonella is an ongoing risk in uncooked poultry and eggs. Consumers are reminded to cook eggs thoroughly before consumption to kill bacteria and prevent illness. Stay updated with food recall alerts and safety guidelines to ensure the health and safety of you and your family.

Remember, food safety is paramount. Keep abreast of the latest FDA warnings and manufacturer recalls to safely navigate any potential health risks associated with contaminated products.

About the FDA

The Food and Drug Administration (FDA) is a U.S. federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA also regulates the nation’s food supply to safeguard against contamination and prevent foodborne illnesses. One of its key functions is monitoring and managing food recalls when potential risks are identified, ensuring that hazardous foods are quickly and effectively removed from the market. The FDA issues alerts to inform the public about foodborne illness outbreaks, working collaboratively with manufacturers to recall affected products and maintain the safety and integrity of the food supply chain.

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Read the FDA release here: https://www.fda.gov/safety /recalls-market-withdrawals-safety-alerts/milos-poultry-farms-llc-recalls-eggs-because-possible-health-risk

Source: FDA

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FDA Approves Game-Changing Nasal Spray for Anaphylaxis Treatment

Published

2 weeks ago

August 30, 2024

Hal Machina

In a landmark decision on August 9, 2024, the U.S. Food and Drug Administration (FDA) approved the first-ever nasal spray, neffy, for the emergency treatment of severe allergic reactions, including anaphylaxis, in individuals weighing at least 30 kilograms (approximately 66 pounds). This approval marks a significant breakthrough in the management of life-threatening allergic reactions, offering a non-injectable form of epinephrine that could transform how patients handle emergency situations.

Breaking Away from Injections: The Significance of Neffy

Traditionally, the treatment of anaphylaxis—a rapid and severe allergic reaction—has relied solely on injectable forms of epinephrine. This method, while effective, poses a challenge for many, particularly children who might fear needles, potentially delaying life-saving intervention. Neffy emerges as an innovative solution, providing epinephrine in a nasal spray form. As highlighted by Dr. Kelly Stone, MD, PhD, of the FDA’s Center for Drug Evaluation and Research, the development of neffy addresses an urgent need by removing the barrier of injection-associated anxiety and facilitating quicker, more accessible treatment.

The Science Behind Neffy

The approval of neffy was based on extensive clinical research involving 175 healthy adults. These studies explored the absorption and effect of neffy compared to traditional injectable epinephrine forms, focusing on indicators such as epinephrine concentration in the blood and the consequent physiological responses like changes in blood pressure and heart rate. The results confirmed that neffy delivers comparable epinephrine levels and physiological effects necessary for treating anaphylaxis effectively. Further research in children over 66 pounds mirrored these findings, showcasing neffy’s efficacy across different age groups.

How Neffy Works

Neffy is administered as a single dose via a nasal spray into one nostril. In cases where symptoms do not improve or worsen, a second dose may be applied using a new unit. It’s imperative for users to seek immediate medical attention after administering neffy to ensure comprehensive care and monitoring.

Considerations and Side Effects

While neffy stands as a revolutionary step forward, it comes with necessary precautions. Individuals with certain nasal conditions, such as nasal polyps or a history of nasal surgeries, may experience altered absorption rates. In such cases, traditional injectable products might be recommended. Users must also be cautious about potential side effects, which can include throat irritation, headache, nasal discomfort, and dizziness among others.

A Forward Leap in Allergy Management

With the introduction of neffy, patients and caregivers now have a less invasive option at their disposal. This development not only expands the tools available for combating severe allergic reactions but also significantly lowers the threshold for timely, effective intervention. The FDA’s fast-track designation of neffy underscores its potential impact, promising a new era of empowerment for those living with severe allergies.

In conclusion, the FDA’s approval of neffy represents a major advance in allergy care, highlighting ongoing innovation in medical treatments and patient care options. As neffy becomes available, it is poised to become a crucial asset in allergy management, enhancing safety and comfort for patients across the United States.

Source: FDA

https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis?utm_medium=email&utm_source=govdelivery

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