Increased cyber-biosecurity for DNA synthesis

Rami Puzis, Dor Farbiash, Oleg Brodt, Yuval Elovici, Dov Greenbaum

Nature Biotechnology 38 (12), 1379-1381, 2020

Some unique functions in FDALabel, not previously available in a single application platform, are particularly useful for addressing broad scientific questions. Drug labeling documents in FDALabel are from FDA’s Structured Product Labeling (SPL) archive, submitted by manufacturers. These consist of semi-structured text wherein much of the critical content is contained in the blocks of unstructured free text. To bring a degree of discoverability and insight to the mass of free text parts among all labeling, we have encoded the labeling information with the standard nomenclature of Medical Dictionary for Regulatory Activities (MedDRA), which is a clinically validated international standard of terminology used by regulatory agencies and industry. The terminology is used in the FDA Adverse Event Reporting System (FAERS) and in coding adverse events in clinical trials, as well as in electronic health records. With …