Abbott falls on plant QSR (US quality system regulation) failure
This article was originally published in Clinica
Executive Summary
Shares in Abbott Laboratories dropped by over 9% last week on the release of an FDA report that found that its Lake County, Illinois, diagnostic plant still failed to meet US quality system regulation (QSR) standards. The plant, which produces lab and hospital blood tests among a range of 400 medical products, had been visited in January 2002 (see Clinica No 994, p 15). This followed an FDA consent decree in 1999, in which Abbott was fined $100 million and had a slew of products removed from the market (see Clinica No 883, p 1).
You may also be interested in...
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.