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# FDA Evaluating Covid Changes to Make Some Permanent
- URL: https://www.fdaweb.com/fda-evaluating-covid-changes-to-make-some-permanent/
- Published: 2020-06-01T12:00:00.000Z
- Updated: 2026-09-14T16:16:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146900

As the U.S. becomes accustomed to living with the Covid-19 pandemic, FDA commissioner **Stephen Hahn** says it is time to look forward and evaluate the agency’s response to identify new opportunities. Addressing the Alliance for a Stronger FDA in a virtual update, Hahn said FDA needs to learn from the work that is being done during the pandemic and apply that experience to the future. “Many policies and procedures were adjusted during the health emergency and it has become clear that a critical look at many traditional policies and processes is needed,” he said. “I've instructed my staff to identify lessons learned to permanently change these beyond the pandemic to make the agency more efficient.”

For example, Hahn said the pandemic gave FDA a fresh look at how clinical trials should be designed and conducted, such as the use of master protocols, which allows the study of more than one promising new drug at time. Expanded access was also liberally used to get drugs to patients not eligible or unable to participate in randomized clinical trials. “That does not mean that the agency is walking away from controlled, randomized clinical trials. and in fact they still form the basis of our regulatory decisions,” he said. During an emergency, FDA needs to show flexibility for patients who are not eligible for expanded access.

Many of the permanent changes that will be made represent an acceleration of where the agency was already headed, such as the concept of decentralized clinical trials, the use of telemedicine in clinical trials, and the flexibility exercised with laboratory test development, Hahn told the Alliance membership. “One area I have great hope for in the future is the use of real world evidence,” he said. As the pandemic brought urgency to FDA’s efforts, available traditional data were used to grant emergency use authorizations (EUA) on the diagnostics and medical device side. Once the device gained market use, Hahn said FDA used real-world evidence, its Sentinel system and other resources to look back at the real-world use of some of the diagnostic tests and medical products and adjusted the EUAs based on that data.

Hahn said there have been some important lessons learned from real-world evidence: it has the potential to better understand a disease, the operating characteristics of tests, and detect potential shortages in the medical supply chain. “We will have more confidence in the use of real-world evidence going forward,” he told the Alliance, adding that speed is important, but corners will not be cut on safety and effectiveness.”

  
Hahn’s pre-recorded [video](https://www.youtube.com/watch?v=vM1Dq7muX50&ref=fdaweb.com) was posted to YouTube.