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.
Administrative law and regulatory proceduresCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government studies and investigationsMedical researchPublic participation and lobbying
A bill to expand patient access to experimental treatments in clinical trials, and for other purposes.
USA115th CongressS-1048| Senate
| Updated: 5/4/2017
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.
Administrative law and regulatory proceduresCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government studies and investigationsMedical researchPublic participation and lobbying