FDA

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.

The Food and Drug Administration’s Center for Tobacco Products is leveraging emerging technologies to drive new efficiencies across its premarket review process, the center’s Office of Science Director Matt Holman said during an FDA meeting last week.

The COVID-19 pandemic has had varying impacts on tobacco and vaping use among youths and adults, but did not have any impact on users’ reported intention to quit, according to recent data from the Food and Drug Administration.

Emerging technologies and advances in infrastructure are making data across federal health agencies more actionable.

The Food and Drug Administration is requesting additional funding in its fiscal year 2022 budget to bolster data modernization, secure and strengthen supply chain, transition to cloud and develop new technology solutions.

• Health IT

HHS’ at-home and self-testing services could help the public maintain health safety amid reopening plans.

Offices within the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) are developing new tools to advance drug development and evaluation processes of generic and new medicines.