FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus
FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus
On November 5, the US Food and Drug Administration published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an emergency use authorization (EUA). If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sibelius in April. This guidance document outlines what information the FDA recommends that manufacturers include in these EUA request.
The EUA authority allows the FDA to authorize use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a declaration of emergency, when certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization is revoked by the FDA.
Although the FDA encourages manufacturers to submit appropriate premarket applications for these tests, the agency also recognizes that it may not be possible to generate complete clinical validation data that would normally be included in an application. However, this guidance outlines information the FDA recommends be included, and the FDA gives these requests thorough and careful review to protect the public health.During this declared public health emergency, manufacturers of 2009 H1N1 influenza virus tests that are unable to submit a complete premarket notification may use the guidance to submit a request for an EUA.
The guidance is available online at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf, and will remain in effect throughout the public health emergency.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
