Antimicrobial susceptibility test guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA's recently released special controls 1guidance on antimicrobial susceptibility test (AST) systems updates a March 2007 document of the same title. The guidance was first issued in 2000 when the agency down-classified short-term incubation cycle AST systems to class II with special controls. The revised guidance includes additional AST labeling instructions for firms to follow when drug makers update antibiotic labeling on bacterial susceptibility to treatment. In June 2008, FDA issued 2guidance to drug makers calling for annual labeling revisions for systemic antibacterial products
You may also be interested in...
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.