FDA

• Data

A new initiative aims to build a “community of interoperability” to improve diagnostics and standards.

• Health care

The agency’s tech posture is helping it review unexpected amounts of applications for new tobacco products.

• HealthCast
• Artificial Intelligence
• Data

A Presidential Innovation Fellow is helping the agency improve workflows and ultimately ensure safety of the drugs and treatments it regulates.

• Digital Services

Data management and digital tools are driving FDA’s efforts to respond to the next wave of COVID-19 demands.

• Health care

A permanent supply chain program will help the agency prevent shortages of medical devices.

• Data

Leveraging patient experience data for product development requires strong workforce readiness.

Following the onset of COVID-19, one office within the Food and Drug Administration leveraged new processes and developed innovative tools to support increased public health demands in regulating medical devices, leaders explained during FDA’s regulatory conference with industry this month.

When COVID-19 was declared a national emergency, the Food and Drug Administration had to act quickly on its oversight responsibilities around the sudden need for new testing, equipment and, ultimately, vaccines.

• Workforce

As agencies modernize their IT infrastructure to remain competitive in the digital ecosystem, leaders are spearheading change management to ensure their workforce is up to speed.

The Food and Drug Administration is advising industry partners on new guidance for identifying and tracing prescription drugs as they move through the distribution supply chain to ensure availability of critical drugs during the pandemic, Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Response, told GovernmentCIO Media & Research.

Changes brought by COVID-19 have produced a corresponding shift in federal cybersecurity posture, particularly among agencies responsible for overseeing health care and medical IT systems.

The Food and Drug Administration is breaking down silos, spearheading new data sharing efforts and upskilling its workforce under its data strategy to turn data into a “strategic asset” and drive new efficiencies.