Enhanced Clinical Trial Design Act of 2017

Summary

Enhanced Clinical Trial Design Act of 2017 This bill requires the Food and Drug Administration (FDA), in coordination with the National Institutes of Health, to convene a meeting to discuss clinical trial inclusion and exclusion criteria. The FDA must report on the meeting and issue guidance regarding eligibility criteria for clinical trials. The Government Accountability Office must report on individual access to investigational drugs for serious conditions through the FDA's expanded access program (i.e., compassionate use). The FDA must streamline review by institutional review boards of expanded access protocols for individual patients. The bill amends the Federal Food, Drug, and Cosmetic Act to require the manufacturer or distributor of an investigational drug for a serious condition that is designated a breakthrough therapy, fast track product, or regenerative advanced therapy to publish its expanded access policy not later than 15 days after the designation.

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Timeline

1. 4 May 2017

   Introduced

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

   Source: IntroReferral

2. 4 May 2017

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 4 May 2017 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 4 May 2017

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 4 May 2017

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 4 May 2017

  Open at official source

Sponsors

• Sen. Hatch, Orrin G. [R-UT] · R · Sponsor
• Michael Bennet · D · Sponsor
• Sen. Burr, Richard [R-NC] · R · Sponsor
• Sen. Casey, Robert P., Jr. [D-PA] · D · Sponsor
• · sshr00 · Standing

Related records

• related to → FDA Reauthorization Act of 2017
• related to ← FDA Reauthorization Act of 2017