The 21st Century Cures Act (Cures Act) was signed into law in 2016, in part to promote interoperability of health information technology (health IT) and reduce information blocking (HealthIT.gov, 2023a). This was not the first legislation introduced by the U.S. Congress targ...
The use of real-world data (RWD) to generate real-world evidence (RWE) has been increasing since it was first introduced in the 21st Century Cures Act in 2016 and, more recently, with the issuance of a series of guidances and frameworks for industry on aspects of RWD and RWE’s role ...
Public Law No: 114-255-H.R.34-21st Century Cures Act. 201, 114–255 2016, pp. 1000–18001. https://www.congress.gov/bill/114th-congress/house-bill/34?q=%7B%22search%22%3A%5B%22To+accelerate+the+discovery%2C+development%2C+and+delivery+of+21st+century+cures%2C+and+for+other+pu...
The 21st Century Cures Act (Public Law 114-255, Section 3093) addressed several of the topics identified in these reports, including VICP protection of both the mother and/or child for vaccines administered during pregnancy and the inclusion of pregnant women in clinical research related to ...
The rise of the highly lethal severe acute respiratory syndrome-2 (SARS-2) as corona virus 2019 (COVID-19) reminded us of the history of other pandemics that happened in the last century (Spanish flu) and stayed in the current century, which include Severe-Acute-Respiratory-Syndrome (SARS)...
We’ve all rolled our eyes at ads for knockoff Ray Bans or dubious ED cures that “doctors HATE.” It’s easy to smirk at them because it’s obvious those are fake accounts. Now imagine those ads backed by the voice or likeness of someone you trust. ...
legislators are recognizing the value of RWE. In the United States, the 21st Century Cures Act passed in December 2016 establishes public-private partnerships to collect data and improve understanding of diseases, supports patient-focused drug development, and modernizes the...
Use of properly developed PRO instruments is a key element of drug development programs using patient-focused end points and for characterization of disease-specific burden with increasing importance given the 21st Century Cures Act requirements. We also see the ADPKD-IS as a tool for researchers an...
Panelist, Legal Impact of The Cures Act on Regenerative MedicineBerkeley Electronic Press Selected WorksMary Ann Chirba
Over the past decade, a first wave of US public policy advocacy for eating disorders made substantial progress, with passage of the federal 21st Century Cures Act in 2016 as its crowning achievement. However, the US response to eating disorders continues to fall short in several ways. On the...