After three years of debate, countless hearings, and pleas from patient advocates, lawmakers on Tuesday approved legislation to speed new medicines to market and to authorize an additional $4.8 billion in spending for medical research. (...) The Cures Act includes numerous provisions that set the stage for the faster approval of prescription drugs and medical devices. (...) Critics had a host of concerns. Representative Rosa DeLauro (D-Conn.) said the bill would weaken regulations on medical devices, allow drugs to be approved with only limited evidence of the drug’s safety and efficacy, and rush the use of new and unproven antibiotics.(...) Cures Act provisions [that] will allow the FDA to consider “real world evidence” when approving drugs and allow companies to submit summaries of study data, rather than full clinical trial records.(...)
