Terrorism Awareness Ready Response Exam
Keri Gamrath
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Today, the FDA announced that it has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States should be monovalent (single strain) JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses.
There continues to be interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals.
Today, the FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
Today you have several treatment options to prevent hospitalization and other serious complications of COVID-19. The FDA has approved drug treatments for COVID-19 and has authorized others for emergency use.
The Food and Drug Administration (FDA) is advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months through 11 years of age to ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial, so that the correct dose is administered to the vaccine recipient.
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula.
On Thursday, the FDA re-issued two temporary guidances originally published during the COVID-19 public health emergency (PHE) for certain regulatory requirements that involve onsite visits abroad under the FDA Food Safety Modernization Act (FSMA).
The FDA posted information regarding the formula for COVID-19 vaccines for the 2023-2024 fall and winter seasons. The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop vaccines with a monovalent XBB.1.5 composition.
The committee will discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. This discussion will include consideration of the vaccine composition for fall to winter, 2023-2024. View webcast.
FDA 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.
On Monday, the FDA and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics.
Today, the FDA updated its new Rumor Control page to provide the facts and inform the public on how the growing spread of rumors, misinformation and disinformation about science, medicine and the FDA is putting patients, consumers and their families at risk.
While the HHS public health emergency is ending, COVID-19 remains a high priority and the U.S. Food and Drug Administration will remain engaged with numerous activities to protect and promote public health.
On Thursday, the FDA issued a safety communication to warn consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics.
Today, the FDA issued a final guidance for industry titled Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products. The FDA intends for this guidance to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products intended to help cigarette smokers stop smoking and for other related indications.
On Thursday, the FDA authorized for marketing the Bateman Bottle Breast Implant Removal System (BIRS), a single-patient, single use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant. The FDA also announced it will reopen the comment period for the draft guidance entitled Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry.
On Monday, the FDA granted marketing authorization to the NTX100 Tonic Motor Activation (NTX100 ToMAc) System to reduce the symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and improve sleep quality among drug-resistant RLS patients.
Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations.
Today, the FDA issued an emergency use authorization (EUA) for the Azure Fastep COVID-19 Antigen Pen Home Test (manufactured by Azure Biotech, Inc.). The test can be used for people aged 14 years or older with a self-collected nasal swab sample and aged 2 years or older when an adult collects the nasal swab sample.
On Monday, the FDA authorized for marketing the MISHA Knee System, an implant placed alongside the knee joint to help reduce the amount of load carried by part of the joint. Additionally, the FDA, in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Reagan-Udall Foundation for the FDA, announced a virtual public meeting on May 10-11 titled, Considerations for Buprenorphine Initiation and Maintenance Care.
Today, the FDA granted marketing authorization for the Masimo SafetyNet Opioid System, a monitoring device intended to recognize and respond by a series of escalating notifications when an individual may be experiencing Opioid Induced Respiratory Depression (OIRD) due to opioid use or overdose.
Today, the FDA completed its second pre-market consultation for a human food made from cultured animal cells. The agency also posted a warning letter issued to www.ivermectin4covid.com for offering drugs for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19.
Today, the FDA issued an emergency use authorization (EUA) for the Cue Mpox (Monkeypox) Molecular Test for use in a point-of-care (POC) setting. The Cue Mpox (Monkeypox) Molecular Test is molecular-based test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of monkeypox by their healthcare provider.
The FDA amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine.
Yesterday, the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination.
Today, the FDA issued a Letter to Health Care Providers about our expanded work to evaluate the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems that have parts made of chlorinated peroxide cured silicone.
The FDA and the Federal Trade Commission have been working to help advance competition for biologics, including biosimilars and interchangeable biosimilars. Together, they have developed an educational resource for consumers about biosimilars and interchangeable biosimilars to help address common misperceptions.
Today, the FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Test is a single-use at-home test kit that provides results from self-collected nasal swab samples in roughly 30 minutes.
On Thursday, the FDA issued a letter to health care providers informing health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators.
On Wednesday, the FDA published the Medical Countermeasures Initiative (MCMi) Program Update report which showcases the FDA's critical role each year in protecting the United States from chemical, biological, radiological and nuclear threats, and emerging infectious diseases, like COVID-19 and mpox.
On Monday, the FDA updated its step-by-step guide to include information about reporting your over-the-counter (OTC) at-home COVID-19 test result to MakeMyTestCount.org. The FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test.
The U.S. Food and Drug Administration today revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency.
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