“A decade after the US Food and Drug Administration (FDA) launched its Sentinel system for active post market surveillance of medical products, officials from the agency say that new technologies such as natural language processing and machine learning will be key to expanding its use going forward.”
“Speaking at the Duke Margolis Center for Health Policy’s Annual Sentinel Initiative public workshop on Wednesday, FDA Commissioner Scott Gottlieb said that Sentinel now has access to data for more than 223 million US patients, with both medical records and pharmacy benefit information for 178 million.”
“Gottlieb also said that FDA has conducted 254 analyses using Sentinel…”
“But despite Sentinel’s usefulness for assessing safety information so far, Gottlieb said the agency must begin to consider how to use Sentinel to answer more complex questions…” Read the full article here.
Source: Sentinel at 10 Years: FDA Looks to New Tech to Expand Surveillance – By Michael Mezher, February 8, 2018. Regulatory Focus.
