News in Brief: A System Called ‘Integrity’; A Definition for Crude Heparin; Confirmation for Written Confirmation
This article was originally published in The Gold Sheet
FDA’s ‘Integrity’ IT platform to watch over global manufacturing network; with help, FDA lab hopes to finally define uncontaminated crude heparin; and EU ‘written confirmation’ doubters converted.
You may also be interested in...
Pharmaceutical identity crisis arises after ingredients are mimicked by cheap, deadly substitutes. Chemical sleuths tell how they found the melamine cyanurate, oversulfated chondroitin sulfate and diethylene glycol that were hidden in pet food, heparin and cold remedies. Efforts to better identify drug ingredients takes on new urgency with melamine spreading to infant formula and rumors of possible attempts to devise a new heparin adulterant. As instrumental compendial tests are added to monographs, industry, legislators, regulators and compendial organizations grapple with broader implications of this new type of adulteration. U.S. Pharmacopeia leadership talks about establishing a massive standardized spectral library that could be accessed using remote analyzers to instantly identify ingredients, impurities and adulterants.
A full appraisal by the UK cost watchdog is not the only way to gauge the safety and effectiveness of Evusheld, argues the independent Drug Safety Research Unit in response to the government’s decision not to buy the licensed COVID-19 drug because of insufficient data on protection.