Antimicrobial susceptibility test guidance
This article was originally published in The Gray Sheet
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...
Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020.
Pfizer has now received a formal European Commission approval for its Nyvepria biosimilar pegfilgrastim. The approval puts the firm in direct competition with several other versions of the Neulasta original.
AstraZeneca's research head admits that the half dose approach was a lucky mistake – but one that could boost the vaccine's effectiveness and supplies. The US regulator may not be persuaded, however.