RT @tomleblancMD: "Data empathy" - an overdue concept in #healthIT and #bigdata work. Below is essential reading on key considerations in #…

RT @SarahKarlin: .@DrAbernethyFDA departing advice on FDA leadership hole....

As for my next steps...I am going to spend some time with my family and do some brainstorming, reading & writing. I’ll be back at it soon, but in the meantime, I am just so grateful to everyone @US_FDA for trusting me to help advance the agency’s mission. 5/5

RT @DrWoodcockFDA: By unleashing the power of real-world evidence, we can accelerate medical product development and bring new innovations…

RT @DrWoodcockFDA: Our new Data Modernization Action Plan is great news for the agency, public health and our stakeholders & it’s the next…

FDA’s Data Modernization Action Plan leverages the foundations laid by our Technology Modernization Action Plan: a modern, cloud-forward technical infrastructure; a product-oriented approach and enhanced collaboration. #FDAVoices

FDA is focused on data & tech modernization that supports real-time analyses to inform regulatory work. E.g., yesterday we launched part 2 of a pilot to use AI to enhance our ability to identify violative imported seafood products ("stinky fish").

Kevin Fu has joined FDA as an expert in residence, our first acting director of medical device cybersecurity in the Center for Devices and Radiological Health (CDRH). Welcome to the FDA team. #becybersmart #cybersecurity

Top line summary from this updated FDA guidance is that patients who receive COVID vaccines & other medical products authorized under EUA do not need to be excluded from clinical trials of investigational products. Great news for patients! There are caveats, so read the guidance.

RT @DrWoodcockFDA: FDA has completed our investigation of the 2020 leafy greens E.coli outbreak. We found the presence of a recurring strai…

RT @DrWoodcockFDA: Producing or distributing drugs that don’t meet FDA quality standards poses a serious risk of harm to patients. This wil…

National Library of Medicine's Pubmed, released in 1996, is a great example of how government action accelerates progress. Pubmed made searching the medical literature easy and free - a catalytic event in the application of research-based evidence to patient care. @FNLM #EBM

Real-world data/evidence (RWD/E) isn't a new field rather an updated name/concept for an evolving field & specific areas of focus. Observational/outcomes research -> comparative effectiveness research/ pharmacoepidemiology -> patient-centered outcomes research/etc -> RWD/E