A bill to provide for the use of emergency use authorization data and real world evidence gathered during an emergency to support premarket applications for drugs, biological products, and devices, and for other purposes.

Summary

This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product. Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval. Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.

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Timeline

1. 29 April 2021

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 29 April 2021

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 29 April 2021 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 29 April 2021

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 29 April 2021

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 29 April 2021

  Open at official source

Sponsors

• Roger Marshall · R · Sponsor
• Tina Smith · D · Sponsor
• Bill Cassidy · R · Sponsor
• · sshr00 · Standing

Related records

No cross-record relationships stored yet.