In May 2015, the “21st Century Cures Act” was introduced in the U.S. House of Representatives with the goal of promoting the development and speeding the approval of new drugs and devices. Championed by the pharmaceutical, biotechnology, and device industries, some of its provisions could have a significant impact on clinical trial design, what is known about the safety and efficacy of medical products, and which medical treatments become available for use.
Related:
- The 21st Century Cures Act — Will It Take Us Back in Time? by Jerry Avorn MD and Aaron Kesselheim MD, JD, MPH, New England Journal of Medicine, Jun. 25, 2015.
- Interview with Dr. Jerry Avorn on the 21st Century Cures Act’s potential implications for drug development and safety. Supplement to the New England Journal of Medicine, Jun. 25, 2015.
- Say NO to Speeding Ineffective and Unsafe Treatments to Market in the Name of Patients, Breast Cancer Action, Jul. 9, 2015.
- The F.D.A.’s Medical Device Problem, by Rita Redberg and Sanket Dhruva, The New York Times, Jul. 17, 2015.
- How Not to Fix the F.D.A. by the Editorial Board, The New York Times, Jul. 20, 2015
- 21st Century Cures Act: A huge step backward for FDA standards, by Trudy Lieberman, Health News Review, Aug. 4, 2015.
