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Kelly Servick, quoting Rachel E. Sachs (Academic Fellow Alumna)
Science
April 7, 2017

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From the article:

“‘Adaptive clinical trials’ is one of those buzzwords that get brought up all the time,” says Rachel Sachs, an innovation and health law professor at Washington University in St. Louis in Missouri, and “there is definitely real momentum to actually do more trials this way.” She notes that in the 21st Century Cures Act, signed into law this past December, Congress required that FDA issue guidance and hold a public meeting to clarify how drug sponsors can use adaptive trials in their submissions for drug and device approvals. Legislation that must pass this year to reauthorize FDA’s user fee program commits the agency to create a pilot program to review such innovative trial proposals and the computer simulations that often guide them.

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biotechnology   fda   health care finance   health law policy   pharmaceuticals   rachel sachs   regulation