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Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union

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In response to a Congressional request, an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will conduct a study on processes for evaluating the safety and efficacy of drugs for rare diseases or conditions in the United States and the European Union.

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Showing 1–12 of 25 items

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Report Launch Event

  • September 27, 2024
  • 1:00 PM - 2:00 PM (EDT)
  • Webinar
  • Past

Please join us for a webinar to learn about this new National Academies’ report, Regulatory Processes for Rare Disease Drugs in the United States and European Union, on Friday, September 27, 2024. Mem...

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Committee Media Training

  • August 20, 2024
  • 11:00 AM - 12:00 PM (EDT)
  • Closed
  • Meeting
  • Past

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Committee Media Training

  • August 16, 2024
  • 11:00 AM - 12:00 PM (EDT)
  • Closed
  • Meeting
  • Past

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Report Review Meeting

  • August 5, 2024
  • 4:00 PM - 5:00 PM (EDT)
  • Closed
  • Meeting
  • Past

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union (Meeting 5 - Hybrid)

  • May 23 - 24, 2024
  • Closed
  • Past

This is the fifth meeting of the committee and will be hybrid with both in-person and virtual participants. The meeting will be closed and will not include a public session.

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Writing Group 2 Meeting

  • May 10, 2024
  • 4:00 PM - 4:30 PM (EDT)
  • Closed
  • Past

This is a closed-session writing group meeting of the consensus study committee members.

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Writing Group 3 Meeting

  • May 7, 2024
  • 3:00 PM - 4:00 PM (EDT)
  • Closed
  • Past

This is a closed-session writing group meeting of the consensus study committee members.

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Writing Group 1 Meeting

  • May 6, 2024
  • 1:00 PM - 2:00 PM (EDT)
  • Closed
  • Past

This is a closed-session writing group meeting of the consensus study committee members.

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Writing Group 2 Meeting

  • May 3, 2024
  • 1:00 PM - 2:00 PM (EDT)
  • Closed
  • Past

This is a closed-session writing group meeting of the consensus study committee members.

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Writing Group 4 Meeting

  • May 1, 2024
  • 1:00 PM - 2:00 PM (EDT)
  • Closed
  • Past

This is a closed-session writing group meeting of the consensus study committee members.

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union - Data Analysis Readout

  • April 24, 2024
  • 10:00 AM - 1:00 PM (EDT)
  • Closed
  • Past

This is a closed-session meeting of the consensus study committee members consisting of a data analysis readout.

Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union (Meeting 4 - Virtual)

  • April 3 - 4, 2024
  • Closed
  • Past

This is the fourth meeting of the committee and will be conducted virtually. The meeting will be closed and will not include a public session.
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