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Are You Ready For The FDA's "Data Effect" Tsunami 8 Steps To Prepare


Are You Ready For The FDA s Data Effect Tsunami? 8 Steps To Prepare
By Matt Collins, CEO, Cignyl; and John Giantsidis, president, CyberActa, Inc.
The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan (TMAP). Announced on March 3, 2021, DMAP is the agency’s overhaul of technology and data with the objective of bringing together increasingly disparate and diverse data sources to help understand and pinpoint emerging public health threats.
This sounds very noble, and using data as the basis of the FDA s regulatory decision-making seems to be an improvement. So, why would this be a tsunami for biotechnology, pharmaceutical, and medical device manufacturers? Do not misunderstand, data turned into knowledge improves understanding, decision-making, and, ultimately, outcomes. Businesses have learned this and are continuously improving their use of analytics as a competitive differentiator. However ....

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Computer Science Meets Medicine in Drug Discovery

FDA lays out data modernization action plan


Dive Brief:
FDA has shared a Data Modernization Action Plan setting out its response to the proliferation and diversification of data sources. Through DMAP, FDA aims to identify and run data projects with measurable value, develop repeatable practices and build a talent network.
FDA is working toward those goals in the belief that even small advances in our ability to gain useful insights from data can represent significant opportunities, Janet Woodcock and Amy Abernethy, respectively the acting commissioner and acting chief information officer at FDA wrote in a blog post.
In 2019, FDA created the Technology Modernization Action Plan. The plan set out the near-term actions the agency proposed to take to equip itself to securely receive, store, exchange, link and analyze data at scale. With the infrastructure plan in place, FDA turned its attention to how it will manage and use data. ....

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