IVDs SHOULD BE VALIDATED IN GROUPS BY LIKE FORMULATION
This article was originally published in The Gray Sheet
Executive Summary
IVDs SHOULD BE VALIDATED IN GROUPS BY LIKE FORMULATION, rather than individually, when assessing a product's accuracy, purity and specificity, the Health Industry Manufacturers Association suggests in April 8 comments on the final draft of FDA's "Guideline for the Manufacture of In Vitro Diagnostic Products." Noting that the latest draft requires prospective validation of each new in vitro diagnostic product, HIMA says the guideline "does not recognize the fact that many formulations are identical in the way that they support (or inhibit) microbial growth."
You may also be interested in...
Beauty Packaging Producers: July Marks Registration Deadline With PRO In Three States
Companies considered producers of single-use packaging in Oregon, Colorado and California must register with Circular Action Alliance, the leading (and currently only) producer responsibility organization, by 1 July 2024 under new state recycling laws.
Metsera Launches As New Obesity Contender Flush With $290m
Clive Meanwell, former CEO of The Medicines Company, will helm the new company, backed by ARCH and other investors. He talked to Scrip about the new venture.
Deal Watch: AbbVie Teams With MedinCell On Long-Acting Injectables
Collaboration Edition: Including deals involving Evotec/Variant, Sanofi/IGM/Nurix, ABVC/OncoX and Harmony/Bioprojet, along with tech transfer agreements and deals in brief.