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The "Resiliency Roadmap" — Next Steps For FDA Inspections - Vimarsana News

The "Resiliency Roadmap" — Next Steps For FDA Inspections

More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the...

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

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 d...

FDA lays out data modernization action plan - Vimarsana News

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 crea...