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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.

USA117th CongressS-1508| Senate 
| Updated: 4/29/2021
Roger Marshall

Roger Marshall

Republican Senator

Kansas

Cosponsors (2)
Bill Cassidy (Republican)Tina Smith (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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
Apr 29, 2021
Introduced in Senate
Apr 29, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • April 29, 2021
    Introduced in Senate


  • April 29, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Drug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesLicensing and registrations

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.

USA117th CongressS-1508| Senate 
| Updated: 4/29/2021
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Apr 29, 2021
Introduced in Senate
Apr 29, 2021
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • April 29, 2021
    Introduced in Senate


  • April 29, 2021
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Roger Marshall

Roger Marshall

Republican Senator

Kansas

Cosponsors (2)
Bill Cassidy (Republican)Tina Smith (Democratic)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesLicensing and registrations