11/11/2023 0 Comments Labq clinical diagnosticsReview priorities of emergency use authorization (EUA) requests for monkeypox (mpox) diagnostic tests,.On September 7, 2022, the FDA issued a guidance, Policy for Monkeypox Tests to Address the Public Health Emergency, that describes: Information for Monkeypox (mpox) Test Developers They may detect the virus that causes monkeypox (mpox) specifically or more generally detect non-variola orthopoxviruses, which includes monkeypox (mpox). Monkeypox (mpox) diagnostic tests are in vitro diagnostic (IVD) devices used to determine if a person is infected with the virus that causes monkeypox (mpox), which is a type of Orthopoxvirus. On the basis of this determination, on September 7, 2022, the Secretary of HHS subsequently declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. On August 9, 2022, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus. Although there is a very low risk of death, there have been reported complications including severe pain, at times requiring hospital admission. usually presents as a rash on the body, face, or genital area. It typically resolves on its own without treatment. Monkeypox (mpox) is a non-variola Orthopoxvirus and is generally not fatal. The variola virus, which causes smallpox and has been eradicated globally, is another type of Orthopoxvirus. Lists of Laboratories Offering Notified Laboratory-Developed Monkeypox (mpox) Tests.FDA Cleared and EUA-Authorized Monkeypox (mpox) Tests.Information for Monkeypox (mpox) Test Developers.In Clinical Research, we live our Mission every day by enabling customers to move rapidly from scientific ideas to approved medicines. We apply innovative technologies, therapeutic expertise and a firm commitment to quality to optimize costs and the time-curve of drug development.Īs the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. With our global presence, we have conducted clinical trials in more than 100 countries to help customers deliver life-changing therapies to improve health. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. We provide comprehensive, integrated drug development, laboratory and lifecycle management services. Our Clinical Research team, who powers our PPD ® clinical research portfolio, are part of our leading global contract research organization (CRO). We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our team of colleagues in clinical research services are at the forefront of getting cures to market.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |