The effort of the Allotrope Foundation to create a common lab data format that is instrument and vendor “agnostic,” allowing for more efficient and compliant analytical and manufacturing control processes, aligns closely with FDA’s lab regulatory objectives, senior industry players involved are stressing.
How the foundation’s effort to create a framework in which analytical data can be readily communicated aligns with the concerns on FDA’s front burner in its review of lab data and practices has been explained by its members at recent public forums.
At an Allotrope “cross-industry workshop” held in October 2014 at the Chicago law office of Drinker, Biddle and Reath, which is acting as the secretariat of the foundation, Bristol-Myers Squibb (BMS) Associate Director of Cheminformatics Dana Vanderwall discussed the alignment of the Allotrope effort with the data standards vision of FDA’s Center for Drug Evaluation and Research (CDER).
He referenced a data standards “vision document” on the CDER website and pointed out that what Allotrope is striving for “fits very much within the long-term vision that FDA has articulated.”
The 2012 CDER “Data Standards Strategy” white paper states that “the vision for CDER’s data standards program is to create an environment where regulatory data and submission information are based on common standards, are available electronically, and available to support advanced analytics to better inform regulatory decisions to improve public health” (link provided below).
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