Cynthia Kelly Discusses Regulatory Mechanisms to Facilitate Medical Countermeasures | Summary and Q&A

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September 18, 2015
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Stanford
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Cynthia Kelly Discusses Regulatory Mechanisms to Facilitate Medical Countermeasures

TL;DR

This talk provides an overview of the regulatory mechanisms and efforts taken by the FDA to facilitate the development and availability of medical countermeasures, with a focus on Ebola vaccines.

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Questions & Answers

Q: How does the FDA determine which regulatory mechanism to use for the approval of medical countermeasures?

The FDA assesses the risk-benefit profile of each potential medical countermeasure individually. Factors such as the seriousness of the disease, availability of alternatives, and potential benefits and risks of the product are considered when deciding on the regulatory pathway.

Q: What is the animal rule, and when is it used for approval?

The animal rule allows the approval of drugs and biologics when human studies are not ethical or feasible. It can be applied when there is a well-understood pathophysiological mechanism, evidence of efficacy in animal studies, and a clear relationship between the animal study endpoint and desired benefit in humans.

Q: How has the FDA facilitated the development of Ebola vaccines?

The FDA has expedited the review of protocols and clinical data, provided consultation and guidance to sponsors and federal partners, and approved emergency expanded access INDs for post-exposure prophylaxis. Multiple clinical trials for Ebola vaccines have been initiated with FDA support.

Q: Do all medical countermeasures require informed consent for emergency use?

Emergency use authorization allows for the use of unapproved products without informed consent under certain circumstances. However, fact sheets are required to inform recipients and healthcare workers about the product's known and potential risks and benefits.

Summary & Key Takeaways

  • The FDA regulates biological products, including vaccines, blood products, and gene therapies, to ensure safety and efficacy.

  • Efforts have been made to increase collaboration and communication between FDA, sponsors, and end-users to speed up the development of medical countermeasures.

  • Various regulatory mechanisms, such as FastTrack, priority review, and the animal rule, are used to accelerate the approval process for medical countermeasures.

  • The FDA has been actively involved in facilitating the development and clinical trials of Ebola vaccines, with multiple trials currently ongoing.

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