21st Century Cures Act: No Cure for an FDA Patent BiasTerry G. Mahn
21st Century Cures Actneglected diseasesEbolaZikaincentivesThe priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in tradiSantos Rutschman, AnaSocial Science Electronic Publishing...
The 21st Century Cures Act was reported out of committee in May on a 51-0 vote. Supporters of the bill hoped the unanimous endorsement would lead to an overwhelming vote in the House, but they are running into last-minute opposition on the eve of the vote. {mosads}The bill includes $8...
A busy week in health IT, with Senate HELP looking beyond the 20thCentury Cures Act, Health Datapalooza in DC and the American Medical Informatics Association convening in San Francisco. — Two of the witnesses at tomorrow’s HELP hearing, Ben Moscovitch and Lucia Savage, are pushing ag...
FDA Releases Work Plan Implementing the 21st Century Cures ActDaniel A. Kracov
Both the FDA guidance document and the 21st Century Cures Act came about due to the opening of a window of opportunity created by the convergence of circumstances. The question is whether the windows of opportunity are competing and how to resolve this competition. This study will investigate ...
FDA Announces Digital Health Innovation Action Plan to Implement 21st Century Cures ActMichele L. BuenafeM. Elizabeth Bierman
ENGLE, P. SYDNEYDuke Law Journal
Barry H. Boise
Daniel A. Kracov