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Why is the FDA Interested in Natural Language Processing (NLP) of Clinical Texts? Applications to Pharmacovigilance and Pharmacoepidemiology

October 24, 2019 By admin

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 

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Filed Under: Artificial Intelligence, Microsoft Azure

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