FDA’s Interest in NLP of Clinical Texts
Improve the efficiency and scientific validity of FDA analyses –
• e.g. application to narratives of individual case safety reports for pharmacovigilance (including IND safety reports, post‐marketing safety reports, literature reports)
Be prepared for regulatory submissions that might use NLP
• e.g. automated population of case report forms (CRFs) in clinical trials
Understand how this technology can support the Evidence Generation and the Learning Healthcare System visions
• e.g. Identification of key information from clinical narratives in EHRs for case classification in the Sentinel System