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FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process

Today, the U.S. Food and Drug Administration granted marketing authorization for the Cue COVID-19 Molecular Test. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. This test is the first at-home over-the-counter (OTC) test for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first ever at-home test authorized using a traditional premarket review pathway for any respiratory illness. 

“Today’s authorization is the first at-home COVID-19 test granted marketing authorization outside of emergency use authorities, representing a new era of consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”

The Cue COVID-19 Molecular Test consists of a single-use Cue COVID-19 test cartridge, a single-use Cue sample wand (nasal swab), and the Cue cartridge reader (sold separately). The test also uses the Cue Health app, which displays results when the test is complete. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the app in about 20 minutes. In a study reviewed by the FDA, this test correctly identified 98.7% of negative and 92.9% of positive samples in individuals with signs and symptoms of upper respiratory infection.

As with all rapid tests, there is a risk of false positive and false negative results. Individuals who test positive for SARS-CoV-2 should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results should be confirmed by a lab-based molecular test if necessary for patient management. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 or another respiratory infection and should seek follow up care with their healthcare provider.

Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The FDA granted the marketing authorization to Cue Health Inc.


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

New jobs posted from, June 3, 2023

Sedgwick CountyJobs
Boundary Change, Sales Legal Support Specialist I - Appraiser - Wichita, KS, US
Administrative Support I - COMCARE - Wichita, KS, US
Seasonal Logistic Support - Wichita, KS, US
Sheriff's Office Therapist - Sheriff - Wichita, KS, US
Mobile Crisis ICS III - COMCARE - Wichita, KS, US
Crisis Integrated Care Specialist III - COMCARE - Wichita, KS, US
General Clinic Nurse Practitioner - HEALTH - Wichita, KS, US
Licensing and Backup, Deputy County Clerk I - CLERK - Wichita, KS, US
Customer Service Associate Front Desk - Health - Wichita, KS, US
WIC Registered Nurse - Health - Wichita, KS, US

Don’t Use Products Marketed to Treat Molluscum, a Common Skin Condition

CU - Molluscum_1600x900_0If you’re bothered by bumps on your skin, don’t try to diagnose yourself or treat your condition with products that haven’t been approved by the U.S. Food and Drug Administration. Instead, visit a health care professional for a proper diagnosis and to make a treatment plan.

One common condition that some people try to self-diagnose and treat is molluscum contagiosum, a skin infection caused by a virus. But by doing so, you run the risk of delaying the diagnosis and treatment of a potentially serious condition. And you might do more harm than good.

The FDA has not approved any prescription or nonprescription (over-the-counter, or OTC) products for the treatment of molluscum.

Symptoms and Causes of Molluscum

Molluscum, also called water warts, is a viral infection that can cause white, pink or flesh-colored bumps. These growths can happen alone or in groups almost anywhere on the skin, including the face, neck, arms, legs, abdomen and genital area. The bumps are rarely on the palms of the hands or soles of the feet.

Sometimes the bumps itch and get irritated. People with a weakened immune system may have larger or more bumps. If you don’t have the condition evaluated by a health care professional, you might not find out if the bumps are molluscum or a symptom of another skin ailment.

Molluscum is an infection common in children, although teens and adults can also get it. Molluscum is transmitted by skin-to-skin contact, including sexual contact, and by sharing clothes or infected objects such as sports equipment. Good hygiene (cleanliness), including washing your hands and keeping them clean, is the best way to avoid getting molluscum.

Molluscum eventually goes away on its own without treatment, usually in six to 12 months. Although in some people it can take up to five years.

If you have molluscum, a skin doctor (dermatologist) or other health care professional can evaluate your symptoms and recommend ways to manage your condition.

There Are No FDA-Approved Products to Treat Molluscum

Do not use products that claim to treat molluscum, even if they say they are “FDA-approved” or “made in an FDA facility.” There are no FDA-approved products to treat molluscum.

It’s likely that unapproved products marketed to treat molluscum do not do what they claim, and the ingredients in them could cause adverse effects (bad reactions). The FDA has received reports of side effects in children and adults associated with some of these products, including skin reddening, abrasion from skin scratching, and permanent scarring.

Many unapproved products claiming to treat molluscum contain essential oils. Even natural substances, such as essential oils, may cause an allergic reaction or irritate sensitive skin.

FDA Conducts Retailer Inspection Blitz, Cracks Down on Illegal Sales of Popular Disposable E-cigarettes

Today, the U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022. The Puff products include Puff Bar. Today’s action underscores the agency’s unwavering commitment to addressing the role retailers and distributors of unauthorized tobacco products play in this concerning public health issue facing America’s youth.

“Protecting our nation’s youth from tobacco products – including disposable e-cigarettes – is a top priority for the FDA,” said FDA Commissioner Robert M. Califf, M.D. “We’re committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law.”

Today’s warning letters are a result of a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth – specifically Puff and Hyde products. The blitz included investigations of hundreds of retailers and distributors across the country. All products cited in the warning letters are disposable e-cigarettes, which are the most commonly used e-cigarette product type among youth. Puff Bar and Hyde were the first and third most popular brands used by youth who reported using e-cigarettes, according to the 2022 National Youth Tobacco Survey. Among youth e-cigarette users, about 20 percent reported usually using Puff Bar or Hyde brand products in 2022. 

“Since becoming director of CTP, I’ve been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well-known to appeal to youth,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we’re committed to taking appropriate action.”

When e-cigarettes lack a marketing authorization order from the FDA, selling or distributing them to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic Act. The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. A majority of recipients of warning letters voluntarily correct the stated violation. However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition to today’s actions among retailers, the FDA issued a warning letter to an importer of Puff Bar in October 2022; that investigation remains ongoing. 

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S. The distribution or sale of unlawfully marketed products is subject to enforcement action.

The FDA remains steadfast in its commitment to protecting youth from the harms of tobacco products by ensuring illegal products are not marketed, sold, or distributed. These efforts include ongoing surveillance of the marketplace to identify violative products, including existing and emerging disposable e-cigarette products. 

In February, FDA filed the agency’s first civil money penalty complaints against four e-cigarette manufacturers; to date, FDA has filed civil money penalty complaints against ten e-cigarette manufacturers. And in October 2022, the first complaints for permanent injunctions were filed against six e-cigarette manufacturers. From January 2021 through May 2023, FDA issued more than 560 warning letters. All of these actions are part of FDA’s standing compliance and enforcement portfolio, and the latest counts of these actions will continue to be reported on a routine basis. FDA will continue to take action against anyone making, distributing, importing, or selling unauthorized e-cigarette products, especially those most used by youth.

Related Information


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Abby Capobianco

New jobs posted from, May 27, 2023

Sedgwick CountyJobs
Administrative Support II - Wichita, KS, US
Administrative Specialist I - District Attorney - Wichita, KS, US
Administrative Support I - Corrections - Wichita, KS, US
Information and Options Specialist - Aging - Wichita, KS, US
WIC Client Care Specialist - Health - Wichita, KS, US
Part Time WIC Client Care Specialist - Health - Wichita, KS, US
Special Projects Coordinator - CDDO - Wichita, KS, US
Information System IT Specialist COVID-19 - Wichita, KS, US
General Clinic Nurse Practitioner - HEALTH - Wichita, KS, US
Graphic and Multimedia Designer COVID-19 - Wichita, KS, US

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.

Paxlovid manufactured and packaged under the emergency use authorization (EUA) and distributed by the U.S. Department of Health and Human Services will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by today’s approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

“While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives,” said Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research. “Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity. The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19.” 

Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug requires, among other things, substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). In considering approval of a drug, the FDA conducts a benefit-risk assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended population. 

The efficacy of Paxlovid was primarily supported by the final results of the EPIC-HR clinical trial. EPIC-HR was a randomized, double-blind, placebo-controlled clinical trial studying Paxlovid for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection. Patients were adults 18 years of age and older with a prespecified risk factor for progression to severe disease or were 60 years and older regardless of prespecified chronic medical conditions. All patients had not received a COVID-19 vaccine and had not been previously infected with COVID-19. Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause through 28 days of follow-up by 86% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment. In this analysis, 977 patients received Paxlovid, and 989 patients received placebo, and among these patients, 0.9% who received Paxlovid were hospitalized due to COVID-19 or died from any cause during 28 days of follow-up compared to 6.5% of the patients who received the placebo.  

Benefit of Paxlovid was observed in patients with prior immunity to the virus that causes COVID-19. Among patients in EPIC-HR who were antibody positive at trial enrollment, the risk of COVID-19-related hospitalization or death from any cause during 28 days of follow-up was 0.2% among the 490 patients treated with Paxlovid compared with 1.7% of the 479 patients receiving placebo. EPIC-SR was another clinical trial that enrolled vaccinated patients with at least one risk factor for progression to severe COVID-19. Although not statistically significant, among these vaccinated patients, there was a reduction in the risk of COVID-19 related hospitalization or death from any cause.  

EPIC-HR and EPIC-SR were randomized controlled trials and provide information about COVID-19 rebound. Data from these two trials showed that rebound in SARS-CoV-2 (RNA or virus) shedding or COVID-19 symptoms occurred in a subset of patients and happened in both the patients receiving Paxlovid and the placebo. Based on the data currently available to the FDA, there is not a clear association between Paxlovid treatment and COVID-19 rebound.

Because of the importance of reducing the risk of significant drug-drug interactions with Paxlovid, the approved label and authorized Fact Sheet for Health Care Providers for the Paxlovid EUA come with a boxed warning with instructions for prescribers. Prescribers should review all medications taken by the patient to assess for potential drug-drug interactions and determine if other medicines that a patient may be taking require a dose adjustment, interruption and/or additional monitoring. Prescribers should consider the benefit of Paxlovid treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed.

In conjunction with today’s approval, the FDA is providing all prescribers with important information for prescribing Paxlovid properly and safely, such as dosing instructions, potential side effects and information regarding drugs that may cause drug-drug interactions with Paxlovid. The most common side effects of taking Paxlovid include impaired sense of taste and diarrhea. Patients should discuss with their health care provider whether Paxlovid is right for them.

Related Information


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


FDA Office of Media Affairs

Cool for the Summer: Keep Your Favorite Salads Chilled

Picnic MealAt your next picnic, let the spotlight shine on your food — not on party crashers like Salmonella or Listeria. When temperatures rise and food safety steps aren’t followed, cold dishes at a cookout are at risk for unsafe bacteria levels. Avoid foodborne illness by following these steps:

Clean: Remember to clean and sanitize all dishes and utensils used to make your salad and wash your hands before and after food prep.

Separate: Use different cutting boards, plates and utensils to avoid spreading bacteria when preparing your raw foods and ready-to-eat cold dishes.

Cook: Make sure the main meat or poultry ingredients used in cold salads (egg salad, chicken salad, etc.) are cooked to safe internal temperatures before mixing:

  • Cook eggs to 160 F.
  • Cook chicken to 165 F.

Although most cold salads use mayonnaise, the danger of foodborne illness lies with the main ingredient, such as eggs or chicken. Make sure they are cooked and chilled at the proper temperature. If you use homemade mayonnaise, follow these guidelines.

Chill: Avoid the Danger Zone (temperatures between 40 F and 140 F) by refrigerating perishable food within two hours — one hour if it’s a hot day (above 90 F). Keep cold foods at an internal temperature of 40 F or below by nestling food in ice or keeping food in a cooler.

For more information about food safety, call the USDA Meat and Poultry Hotline at 1-888-MPHotline (1-888-674-6854) or email [email protected] to reach a food safety specialist or chat live at from 10 a.m. to 6 p.m. Eastern Time, Monday through Friday.

FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria

Today, the U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older. 

According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines.

“The FDA is dedicated to supporting the development of safe and effective treatment options for infections caused by difficult-to-treat bacteria like Acinetobacter baumannii-calcoaceticus complex,” said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research. “Today’s approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation’s hospitals.”

Acinetobacter baumannii-calcoaceticus complex (henceforth referred to as A. baumannii) includes four species of bacteria in the Acinetobacter family. These bacteria can cause infections in various parts of the body, occurring most frequently in healthcare settings and predominantly causing pneumonia. A. baumannii can become highly resistant to multiple antibacterial drugs and current treatment options for drug-resistant A. baumannii are limited.  

Xacduro consists of sulbactam, a drug structurally related to penicillin, and durlobactam. Sulbactam kills A. baumannii whereas durlobactam protects sulbactam from being degraded by enzymes that may be produced by A. baumannii. Xacduro is administered by intravenous infusion.
Xacduro’s efficacy was established in a multicenter, active-controlled, open-label (investigator-unblinded, assessor-blinded), non-inferiority clinical trial in 177 hospitalized adults with pneumonia caused by carbapenem-resistant A. baumannii. Patients received either Xacduro or colistin (a comparator antibiotic) for up to 14 days. Both treatment arms also received an additional antibiotic, imipenem/cilastatin, as background therapy for potential HABP/VABP pathogens other than Acinetobacter baumannii-calcoaceticus complex. The primary measure of efficacy was mortality from all causes within 28 days of treatment in patients with a confirmed infection with carbapenem-resistant A. baumannii. Of those who received Xacduro, 19% (12 of 63 patients) died, compared to 32% (20 of 62 patients) who received colistin; this demonstrated that Xacduro was noninferior to colistin.
The most common adverse reaction with Xacduro was liver function test abnormalities. Xacduro comes with certain warnings and precautions, such as hypersensitivity reactions and Clostridiodes difficile-associated diarrhea. 

Patients should not receive Xacduro if they have a history of known severe hypersensitivity to components of Xacduro, sulbactam or other beta-lactam antibacterial drugs. 

The FDA granted Xacduro Fast Track, Qualified Infectious Disease Product and Priority Review designations for this application. 

The FDA granted the approval of Xacduro to Entasis Therapeutics.

Related Information

FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder

Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine. 

“Buprenorphine is an important treatment option for opioid use disorder. Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery,” said FDA Commissioner Robert M. Califf, M.D. “The FDA will continue to take the critical steps necessary to pursue efforts that advance evidence-based treatments for substance use disorders, which is a strategic priority under the FDA’s Overdose Prevention Framework.”

Buprenorphine is a safe and effective medication for the treatment of OUD. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), patients receiving medication for their OUD cut their risk of death from all causes in half.

The FDA continues to implement a comprehensive approach to increase options to treat OUD. Earlier this month, the agency issued a joint letter with SAMHSA to clarify the importance of counseling and other services as part of a comprehensive treatment plan for OUD, and to also reiterate that supplying buprenorphine should not be made contingent upon participation in such services. The agency also held a virtual public workshop that highlighted the need for additional strengths and dosing regimens for extended-release formulations. 

Brixadi is approved in both weekly and monthly subcutaneous injectable formulations at varying doses, including lower doses that may be appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available. The weekly doses are 8 milligrams (mg), 16 mg, 24 mg, 32 mg; and the monthly doses are 64 mg, 96 mg, 128 mg. The approved weekly formulation in various lower strengths offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence. Brixadi will be available through a Risk Evaluation and Mitigation Strategy (REMS) program and administered only by health care providers in a health care setting.

The most common adverse reactions (occurring in ≥5% of patients) with Brixadi include injection-site pain, headache, constipation, nausea, injection-site erythema, itchy skin at the injection site (injection-site pruritus), insomnia and urinary tract infections. 

The safety and efficacy of Brixadi were evaluated in a behavioral pharmacology study assessing the ability of two weekly doses of Brixadi to block the subjective effects of opioids, and one randomized, double-blind, active-controlled clinical trial in 428 adults with a diagnosis of moderate-to-severe OUD. After an initial test dose of transmucosal buprenorphine, patients were randomized to treatment with Brixadi plus a sublingual placebo, or active sublingual buprenorphine plus placebo injections. After titration over the first week, patients were treated with weekly injections over 12 weeks and then transitioned to monthly injections for an additional 12 weeks. A response to treatment was measured by urine drug screening and self-reporting of illicit opioid use during the treatment period. Patients were considered responders if they had negative opioid assessments at the end of each of the two treatment phases. The proportion of patients meeting the responder definition was 16.9% in the Brixadi group and 14.0% in the sublingual buprenorphine group. 

The FDA granted approval of Brixadi to Braeburn Inc.

The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. through its FDA Overdose Prevention Framework. The framework’s priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.

Related Information


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.