Information Extraction From FDA Drug Labeling to Enhance Product-Specific Guidance Assessment Using Natural Language Processing.

Towards the objectives of the UnitedStates Food and Drug Administration (FDA) generic drug science and research program, it is of vital importance in developing product-specific guidances (PSGs) with recommendations that can facilitate and guide generic product development. To generate a PSG, the assessor needs to retrieve supportive information about the drug product of interest, including from the drug labeling, which contain comprehensive information about drug products and instructions to physicians on how to use the products for treatment. Currently, although there are many drug labeling data resources, none of them including those developed by the FDA (e.g., Drugs@FDA) can cover all the FDA-approved drug products. Furthermore, these resources, housed in various locations, are often in forms that are not compatible or interoperable with each other. Therefore, there is a great demand for retrieving useful information from a large number of textual documents from different data resources to support an effective PSG development. To meet the needs, we developed a Natural Language Processing (NLP) pipeline by integrating multiple disparate publicly available data resources to extract drug product information with minimal human intervention. We provided a case study for identifying food effect information to illustrate how a machine learning model is employed to achieve accurate paragraph labeling. We showed that the pre-trained Bidirectional Encoder Representations from Transformers (BERT) model is able to outperform the traditional machine learning techniques, setting a new state-of-the-art for labelling food effect paragraphs from drug labeling and approved drug products datasets.