NDA Data Standardization Efforts Emerging Along Public, Private Fronts
FDA appears to be using a multi-front strategy for designing and implementing plans to standardize electronic data formats and application filings.
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Research Consortia Need Funding, But FDA Is More “Honest Broker”
FDA wants data standards in place so the increasingly popular clinical research collaborations can continue growing, but a researcher states that government also could make funding available to sustain the consortia.
CDER Wants To Become “Lean”; Plans Process Analysis
Strategic plan says CDER will streamline its processes and may find activities that could be “cut altogether.”
FDA Chief Operating Officer Brings IT Experience From CDC, Sodexo
Walter Harris, who also worked at the VA and HUD, will oversee FDA’s IT, budget, management and equal employment opportunity functions as head of the Office of Operations, one of four directorates that form a managerial layer between the Office of the Commissioner and the agency’s center directors.