Posted 01 June 2020 | By
The US Food and Drug Administration (FDA) will look to permanently implement some of the processes and policies adopted in its response to the coronavirus disease (COVID-19) pandemic, FDA Commissioner Stephen Hahn said during a virtual briefing hosted by the Alliance for a Stronger FDA on Monday.
Hahn’s statements during the briefing closely mirrored statements he made in a pre-recorded video FDA uploaded to YouTube on Friday.
“As this pandemic has evolved, it was clear to all of us that some FDA processes needed to be adjusted to accommodate the urgency of the pandemic and I think the entire FDA team has now seen first-hand that we need to take a critical look at some of our processes and policies,” Hahn said.
Hahn added that many of the changes the agency will implement “represent an acceleration of where we were headed before,” and include support for decentralized clinical trials, greater use of telemedicine technology in clinical trials and work related to laboratory-developed tests.
Hahn said he has instructed FDA staff “to identify the lessons learned from this pandemic and what adjustments may be needed, not just to manage this or future emergencies, but how to permanently make FDA more efficient in carrying out [its] regulatory responsibilities.”
Additionally, Hahn said FDA is using real-world evidence to monitor the use of medical products during the pandemic. “We very much used real-world evidence and our Sentinel system and other resources to look back at the real-world use of diagnostic tests and medical products and then adjust our authorizations based on that,” he said, adding that real-world evidence can also help “to better understand disease, describe and measure immunity [and] understand the operating characteristics of tests.”
Hahn also addressed conflict of interest concerns stemming from the role of Center for Drug Evaluation and Research (CDER) Director Janet Woodcock and Center for Biologics Evaluation and Research (CBER) Director Peter Marks in overseeing the review of products developed to treat or prevent COVID-19.
Woodcock and Marks were both initially slated to take leadership roles on the Trump administration’s Operation Warp Speed. Shortly after the announcement, Marks left his new role to focus on heading CBER, while Woodcock was temporarily reassigned to the Office of the Commissioner during her work on Operation Warp Speed.
“We have been very clear in writing, but also verbally, that we will maintain our regulatory independence, so that Janet [Woodcock] will not participate in the regulatory decisions around therapeutics and Peter and I will stay outside of any decision-making that Operation Warp Speed has to make with respect to medical products so that we can maintain our independence,” Hahn said.
Hahn’s statements during the briefing closely mirrored statements he made in a pre-recorded video FDA uploaded to YouTube on Friday.
“As this pandemic has evolved, it was clear to all of us that some FDA processes needed to be adjusted to accommodate the urgency of the pandemic and I think the entire FDA team has now seen first-hand that we need to take a critical look at some of our processes and policies,” Hahn said.
Hahn added that many of the changes the agency will implement “represent an acceleration of where we were headed before,” and include support for decentralized clinical trials, greater use of telemedicine technology in clinical trials and work related to laboratory-developed tests.
Hahn said he has instructed FDA staff “to identify the lessons learned from this pandemic and what adjustments may be needed, not just to manage this or future emergencies, but how to permanently make FDA more efficient in carrying out [its] regulatory responsibilities.”
Additionally, Hahn said FDA is using real-world evidence to monitor the use of medical products during the pandemic. “We very much used real-world evidence and our Sentinel system and other resources to look back at the real-world use of diagnostic tests and medical products and then adjust our authorizations based on that,” he said, adding that real-world evidence can also help “to better understand disease, describe and measure immunity [and] understand the operating characteristics of tests.”
Hahn also addressed conflict of interest concerns stemming from the role of Center for Drug Evaluation and Research (CDER) Director Janet Woodcock and Center for Biologics Evaluation and Research (CBER) Director Peter Marks in overseeing the review of products developed to treat or prevent COVID-19.
Woodcock and Marks were both initially slated to take leadership roles on the Trump administration’s Operation Warp Speed. Shortly after the announcement, Marks left his new role to focus on heading CBER, while Woodcock was temporarily reassigned to the Office of the Commissioner during her work on Operation Warp Speed.
“We have been very clear in writing, but also verbally, that we will maintain our regulatory independence, so that Janet [Woodcock] will not participate in the regulatory decisions around therapeutics and Peter and I will stay outside of any decision-making that Operation Warp Speed has to make with respect to medical products so that we can maintain our independence,” Hahn said.
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June 02, 2020 at 04:06AM
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Hahn: FDA will make some changes amid COVID-19 permanent - Regulatory Focus
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