ADAPT 2.0 Act

Summary

Accelerated Drug Approval for Prescription Therapies 2.0 Act or the ADAPT 2.0 Act This bill allows applicants seeking Food and Drug Administration (FDA) approval to market a new drug to rely on investigations conducted in certain other countries and addresses related issues. If an applicant seeks market approval for a new drug with an application that relies on at least one investigation that the applicant did not conduct and did not obtain approval to use, the applicant may rely on an investigation that was conducted in certain foreign countries if the drug in question has already been approved in that country. The investigation must have been conducted in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the United Kingdom, the European Union, a country in the European Economic Area, or another country that the FDA has found to meet certain requirements. The FDA must make a decision on such an application within 90 days of the application's filing. If the FDA does not take certain actions within that period, the application shall be considered approved. The FDA may require the applicant to conduct postapproval studies of the drug and to submit copies of all promotional materials. The bill also establishes an advisory committee to provide the FDA with recommendations as to each application that relies on a foreign investigation. The FDA must make available on its public website each decision on such an application, including the rationale for the decision and the advisory committee's recommendations.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 3 February 2022

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 3 February 2022

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 3 February 2022

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.