Vid Desai On How US FDA’s Modernization Will Improve Inspections And Drug Reviews

 
• By Brenda Sandburg
  
Generate a summary of this article
Listen to this article
Beta

FDA’s chief information officer talks to the Pink Sheet about why the agency relied on COVID data from foreign countries, and describes pilot projects to target inspections and manage warehouse data.

Modernization
US FDA's data and technology modernization is transforming the agency's operations • Source: Shutterstock

While the pandemic has consumed the resources of the Food and Drug Administration over the past two years, the agency has also focused on another issue central to its operations: the modernization of its data and technology. The topic can be hard to grasp given the terminology of information technology, but it is the engine fueling everything from inspections to drug reviews and postmarket surveillance, and it has long been in need of an overhaul.

FDA Commissioner Robert Califf highlighted the agency’s modernization efforts at an April hearing of the Senate Appropriations Subcommittee on the...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from US FDA

PS-AgencyLeadership (Premium-1): Study Reveals How Immune System of Astronauts Breaks Down

Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.

Nancy Test Circulable Section Geography

 
• By Brian Bossetta

This is a short description

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

More from Agency Leadership

New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 
• By Sarah Karlin-Smith

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.