FDA’s “Data Effect” Tsunami – Steps To Prepare

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.
The FDA’s initiative could have significant and costly ramifications for manufacturers, whether in biotechnology, digital health, pharmaceuticals, and anywhere in between. However, by following mDMAP we can mitigate the likelihood of regulatory scrutiny. Starting your mDMAP (manufacturer Data Modernization Action Plan) integration voyage now allows you to stay ahead of the data management curve and protects your business. More importantly, your mDMAP journey will provide greater understanding and help you proactively pivot using the voice of your customers. The proactive capability drives your ultimate goal of doing well by doing good. Or, said another way, we ensure safe and effective outcomes through measured and consistent approaches.
Author(s)Source
Collins M, Giantsidis JMed Device Online 05.05.2021
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