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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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